Booster Link: June 2021

Tuesday, June 29, 2021

Booster may be needed for J&J shot as Delta variant spreads; some experts already taking them - ABC27

by: Reuters, via Nexstar Media Wire

Posted: Jun 29, 2021 / 02:02 PM EDT/ Updated: Jun 29, 2021 / 02:02 PM EDT

THORNTON, CO – MARCH 06: Used vials of the Johnson & Johnson COVID-19 vaccine, the newest vaccine approved by the U.S. FDA for emergency use, sit in a box at an event put on by the Thornton Fire Department on March 6, 2021 in Thornton, Colorado. Colorado entered COVID-19 vaccination Phase 1B.3 on Friday, allowing essential grocery and agriculture workers, people over the age of 60 and people with two or more high-risk conditions to receive a vaccine. (Photo by Michael Ciaglo/Getty Images)

(Reuters) — Infectious disease experts are weighing the need for booster shots of the Pfizer/BioNTech or Moderna mRNA-based vaccines for Americans who received Johnson & Johnson’s one-dose vaccine due to the increasing prevalence of the more contagious Delta coronavirus variant.

A few say they have already done so themselves, even without published data on whether combining two different vaccines is safe and effective or backing from U.S. health regulators. Canada and some European countries are already allowing people to get two different COVID-19 shots.

The debate centers on concerns over how protective the J&J shot is against the Delta variant first detected in India and now circulating widely in many countries. Delta, which has also been associated with more severe disease, could quickly become the dominant version of the virus in the United States, Centers for Disease Control and Prevention Director Rochelle Walensky has warned.

There is no substantial data showing how protective the J&J vaccine is against the new variant. However, UK studies show that two doses of either the Pfizer/BioNTech or AstraZeneca vaccines are significantly more protective against the variant than one.

Andy Slavitt, former senior pandemic advisor to U.S. President Joe Biden, raised the idea this week on his podcast. At least half a dozen prominent infectious disease experts said U.S. regulators need to address the issue in short order.

“There’s no doubt that the people who receive the J&J vaccine are less protected against disease,” than those who get two doses of the other shots, said Stanford professor Dr. Michael Lin. “From the principle of taking easy steps to prevent really bad outcomes, this is really a no brainer.”

The CDC is not recommending boosters, and advisors to the agency said at a public meeting this week there is not yet significant evidence of declining protection from the vaccines.

Jason Gallagher, an infectious diseases expert at Temple University’s School of Pharmacy, recently received a Pfizer dose at the Philadelphia vaccine clinic where he has been administering shots. He got the J&J vaccine in a clinical trial in November.

Gallagher said he was concerned about the UK data showing lower efficacy against the Delta variant for people who received one vaccine dose.

“While the situation has gotten so much better in the U.S., the Delta variant that’s spreading … and really quickly taking over in the U.S. looks a little more concerning in terms of the breakthrough infections with the single-dose vaccines,” he said. “So I took the plunge.”

Cases, hospitalizations and deaths have plummeted in the United States with 56% of the adult population fully vaccinated.

J&J said it is testing whether the immune response from its vaccine is capable of neutralizing the Delta variant in a laboratory setting, but no data is available yet.

Both mRNA vaccines showed efficacy rates around 95% in large U.S. trials, while J&J’s vaccine was 66% effective in preventing moderate-to-severe COVID-19 globally when more contagious variants were circulating.

Dr. Angela Rasmussen, a researcher at the University of Saskatchewan’s Vaccine and Infectious Disease Organization, said on Twitter she had gotten a dose of Pfizer’s vaccine this week after receiving J&J’s in April.

Rasmussen, who declined to be interviewed, encouraged Americans who received the J&J vaccine to talk to their doctors about a possible second shot.

“If you live in a community with overall low vaccination, I’d suggest you strongly consider doing so,” she tweeted.

Vaccine expert Dr. Peter Hotez from Baylor College of Medicine in a tweet said adding a second J&J dose or one of the mRNA vaccines might provide broader protection, “but we need data and CDC-FDA guidance.”

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) is running a trial to determine the need for boosting all currently authorized shots with another dose of Moderna’s vaccine. NIAID scientist Dr. John Beigel told Reuters the agency hopes to have that data by September to help inform regulators’ decisions on boosters.

As long as case counts remain low in the United States, J&J recipients should wait for more data, he said.

If Delta variant-driven infections and hospitalizations increase significantly, he said, “then decisions might need to be made with an absence of data. But right now, I do think it’s appropriate that they wait.”

Reporting by Michael Erman; Editing by Caroline Humer and Bill Berkrot.

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June 30, 2021 at 01:02AM
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Booster may be needed for J&J shot as Delta variant spreads; some experts already taking them - ABC27

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Russia Allows Booster Shots 6 Months After Vaccination | Health News | US News - U.S. News & World Report

[unable to retrieve full-text content]Russia Allows Booster Shots 6 Months After Vaccination | Health News | US News U.S. News & World Report The Link Lonk

June 29, 2021 at 11:29PM
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Russia Allows Booster Shots 6 Months After Vaccination | Health News | US News - U.S. News & World Report

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S.Korea to secure more mRNA vaccines for COVID-19 booster shot - Reuters

Signs and age groups are shown for the Pfizer and Moderna vaccines at a vaccination center as California opens up vaccine eligibility to any residents 16 years and older during the outbreak of coronavirus disease (COVID-19) in Chula Vista, California, U.S., April 15, 2021. REUTERS/Mike Blake/File Photo

SEOUL, June 29 (Reuters) - South Korea plans to secure more mRNA vaccines against COVID-19 to use them as a booster shot next year for its entire population, Prime Minister Kim Boo-kyum said on Tuesday.

South Korea has already agreed to buy 106 million doses of mRNA vaccines from Pfizer (PFE.N) and Moderna (MRNA.O) to cover full vaccination of its population of 52 million this year.

The government is also hoping to achieve herd immunity earlier than its November target by inoculating at least 70% of its population with a minimum of one vaccine dose.

"The government plans to first secure vaccine supply, mostly mRNA ones, enough to vaccinate the entire public with at least one shot next year," Kim said.

South Korea has given at least one dose of the COVID-19 vaccine to around 30% of its population, and large manufacturing employers will start inoculating their employees at their in-house clinics next month. read more

Kim also said it was necessary to broaden the age group of people eligible for vaccination to ensure students can safely return to schools in the autumn amid the spread of more infectious variants. It is also unclear how long immunity protection lasts on those people who have already been vaccinated.

Pfizer's shot has been approved for 12-15 year olds in Europe and the United States, and Moderna is aiming for approval for teenagers as data showed its shot has been found safe and effective. read more

In South Korea, the government has approved the use of the Pfizer vaccine on 16-year olds and above, while the Moderna shot can be given to those aged 18 and older.

While the number of daily local infections have remained below 700 since early this month, more transmissible variants are on the rise.

South Korea has so far reported a total of 2,492 cases of COVID-19 variants, of which 83% were the Alpha variant, first detected in Britain, and 10% were the Delta variant, first identified in India, according to data from Korea Disease Control and Prevention Agency.

South Korea reported 595 new cases of COVID-19 on Monday, raising the total number of confirmed cases to 156,167. The total caseload includes early infections not linked to several variants that the World Health Organization identified this year.

The death toll from COVID-19 stands at 2,017.

Reporting by Sangmi Cha; Editing by Miyoung Kim and Ana Nicolaci da Costa

Our Standards: The Thomson Reuters Trust Principles.

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June 29, 2021 at 12:26PM
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S.Korea to secure more mRNA vaccines for COVID-19 booster shot - Reuters

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Pfizer, CDC experts don't see eye to eye on COVID-19 boosters, threatening key revenue stream: analysts - FiercePharma

When will someone need a COVID-19 booster? Not only is it a pertinent question among the vaccinated, but also among analysts eager to track pandemic vaccine sales for years to come.

In Pfizer’s eyes, it could be that those inoculated with the drugmaker’s BioNTech-partnered shot will need a dose as early as this fall. However, a key CDC advisory panel may not see eye to eye, Bernstein analysts pointed out in a note sent to clients on Monday.

No one is completely sure when a booster will be needed, but it’s possible that some of those who were vaccinated early on may need an extra jab as early as September, or roughly 8 to 12 months after their initial regimen, CEO Albert Bourla recently told Axios. Bourla warned those predictions are preliminary.

Several variants of SARS-CoV-2—the coronavirus behind COVID-19—have been found to spread more rapidly than the original strain, which has caused some concerns about how well the currently-deployed jabs will hold up. Pandemic heavyweights have quickly kicked off research into boosters, whether that's an extra dose of their original shots or a modified version.

Pfizer is working on two different booster-shot strategies that it anticipates could carry sales beyond the immediate pandemic need. Those are a third 30 mg dose of its current vaccine and an updated jab that targets the Beta variant, first identified in South Africa. The company is expecting immunogenicity data for both studies as early as July.

The drugmaker has generally argued that boosters will be required “as antibody blood concentration wanes to ensure the broad population can't carry the virus and thus quench the epidemic faster,” the Bernstein analysts, led by Ronny Gal, wrote to clients. That’s not the industry’s standard, and it’s also not what the CDC’s Advisory Committee on Immunization Practices (ACIP) suggested at its meeting last week, the analysts wrote.

It’s likely that a booster will be necessary once there’s a demonstrated decline in efficacy, not just a waning antibody response, CDC experts said. Boosters may also be needed if there’s a variant that’s able to evade the jabs, according to slides presented by Sara Oliver, M.D., a medical epidemiologist with CDC's National Center for Immunization and Respiratory Diseases.

At the moment, there’s no evidence to suggest a booster is needed, the experts said. Still, boosters could soon be appropriate for some populations. To be sure, the nation's top public health officials will continue monitoring the situation.

“For now, it seems that if the ACIP view is accepted, frequent boosting would be recommended only for special risk groups (elderly, immune-suppressed) or if we learn symptomatic disease quickly follows antibody decline (which is less likely),” the Bernstein analysts said in the note.

A Pfizer spokesperson told Fierce Pharma that the company's "current thinking is that until we see a reduction in SARS-CoV-2 circulation and COVID-19 disease, we think it is possible that a third dose, a boost of our vaccine, could be needed to help provide protection against COVID-19," subject to regulatory approval.

The jury is still out on when exactly the protection from Pfizer’s mRNA shot will begin to fade, although there’s mounting evidence that it may not be anytime soon.

According to one new study published Monday in Nature, the vaccines from Pfizer-BioNTech and Moderna appear to trigger a strong and durable immune response in the body. The researchers found that vaccination led to high levels of neutralizing antibodies effective against three variants of the virus, including the Beta variant.

Boosters are expected to serve as a key revenue driver in the years to come for COVID-19 vaccine heavyweights such as Pfizer and Moderna. Pfizer executives have said the company sees the vaccine market evolving as the pandemic wanes, and that the company will likely be able to charge more per dose than it was getting under pandemic supply deals.

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June 29, 2021 at 02:38AM
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Pfizer, CDC experts don't see eye to eye on COVID-19 boosters, threatening key revenue stream: analysts - FiercePharma

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Monday, June 28, 2021

AstraZeneca Booster Shot Lifts Immune Response, Study Finds - The New York Times

A third dose of the Covid-19 vaccine developed by AstraZeneca and the University of Oxford generated a strong immune response in clinical trial volunteers, Oxford researchers reported on Monday.

The finding indicates that the AstraZeneca vaccine could be an option should third shots end up being needed, for example, to extend immunity. To date, the vaccine has been given as two doses, typically between four and 12 weeks apart.

The new data, detailed in a preprint manuscript that has not yet been peer reviewed, came from 90 study volunteers in Britain who were among the earliest to receive the shots in a clinical trial last year. This past March, they were given a third dose, roughly 30 weeks after their second.

Laboratory analyses showed that the third dose increased levels of antibodies to the virus in the volunteers to a point higher than seen a month after their second dose — an encouraging sign that the third shot would be likely to bring greater protection if the effectiveness of two doses waned over time.

“We do have to be in a position where we could boost if it turned out that was necessary,” Prof. Andrew Pollard, an Oxford researcher who has led studies of the vaccine, said in a news conference on Monday. “I think we have encouraging data in this preprint to show that boosters could be used and would be effective at boosting the immune response.”

Scientists and policymakers do not yet know whether booster shots may be needed.

Scientists reported Monday that the vaccines made by Pfizer-BioNTech and Moderna set off a persistent immune reaction in the body that may protect against the coronavirus for years, but it isn’t clear if the same is happening with other vaccines, including AstraZeneca.

Emerging coronavirus variants could also accelerate the need for booster shots. If third shots are deemed necessary in the coming months, their availability could be severely limited, especially in poorer countries that are lacking enough supply to give first doses to their most vulnerable citizens.

Earlier this month, the National Institutes of Health announced that it has begun a new clinical trial of people fully vaccinated with any of the three authorized vaccines in the United States. The goal is to test whether a booster shot of the vaccine made by Moderna will increase their antibodies against the virus. Initial results are expected later this summer.

The AstraZeneca vaccine has won authorization in 80 countries since last December but is not approved for use in the United States, which already has more than enough doses of its three authorized vaccines to meet demand. The shot has been the backbone of the struggling Covax program to provide vaccines to poor countries, accounting for more than 88 percent of the doses shipped out to middle- and low-income nations through last week.

AstraZeneca announced on Sunday that the first volunteers had been vaccinated in a separate study assessing a new version of the vaccine designed to protect against the Beta variant of the virus first seen in South Africa. Some study results suggested that the original version of the AstraZeneca vaccine may not be effective against that variant. Professor Pollard said the study would compare the effects of a third dose of the original vaccine against those of boosting volunteers with the new Beta-targeted vaccine.

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June 28, 2021 at 06:00PM
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AstraZeneca Booster Shot Lifts Immune Response, Study Finds - The New York Times

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Will the COVID-19 vaccine require a booster? Local doctor says more data is needed - WPRI.com

PROVIDENCE, R.I. (WPRI) — A little more than six months ago, the first COVID-19 vaccine was administered in Rhode Island.

It was a historic day, and since then, more than 1.2 million doses have been administered in the state, according to the latest data from the R.I. Department of Health. As of Monday, nearly 629,000 Rhode Islanders were fully vaccinated, which is almost 60% of the state’s population.

“I think Rhode Island’s done really well in terms of vaccination and getting fully vaccinated,” said Dr. Karen Tashima, the director of clinical trials at Lifespan’s Immunology Center at The Miriam Hospital.

Tashima is also leading the state’s clinical trials for the Novavax vaccine, which could become another tool in the fight against the coronavirus.

“We’re ejecting the protein, plus an adjuvant that helps the immune system respond to that protein, and so that’s what your body is making antibodies to is the spiked protein,” Tashima explained.

There are conflicting reports about whether those who received the Pfizer or Moderna vaccine will need a booster shot in the coming months. Tashima said it’s still unclear and more data is needed.

“We know that for at least six months it looks good, but we’re waiting for the one year from the Pfizer and Moderna study to be released,” Tashima said. “We’ve seen the COVID rates go way down so we don’t think there’s a lot of transmission right now.”

Tashima said all of the drug companies could be getting ready to produce booster shots.

“I think there is anticipation that we might need boosters, and that’s just being extra preparatory,” she said. “We want to be prepared for the actuality that we might need a vaccine booster, but I think they’re just being cautious.”

For anyone who’s coming up on six months from receiving their second dose, Tashima assured they should be confident with the vaccine.

“Go about your daily life and wait for some updates from the clinical trials,” she said.

As for the Delta variant going around, Tashima said those who received the Pfizer and Moderna vaccines are still mostly protected.

“88% is great. It’s still really really good,” she said. “The Delta variant will probably become a very predominant strain here. It’s already happening, we should be aware of that.”

In the meantime, some infectious disease experts are deciding whether the single-dose Johnson & Johnson vaccine could require a booster shot of one of the other vaccines to help protect against the Delta variant.

Tashima recommended following the CDC’s guidelines if you’re fully vaccinated, but if you plan to go into a big crowd and don’t know who else is vaccinated, she said it’s OK to wear a mask as a precaution.

The Link Lonk

June 29, 2021 at 05:58AM
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Will the COVID-19 vaccine require a booster? Local doctor says more data is needed - WPRI.com

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COVID-19 BOOSTER: Mayo Clinic addresses vaccine booster questions - KTTC

ROCHESTER, Minn. (KTTC) -- Now that you've received all of your recommended COVID-19 vaccine doses, you are considered to be protected from the virus.

But could you need a booster? And if so, when?

"Right now, there is no official recommendation for a booster," said Dr. Greg Poland, an Infectious Disease Professor of Medicine at Mayo Clinic.

Poland also said there is currently early testing going on to determine if a booster may be needed some time in the future.

"It's appropriate for us to be prepared," Poland said. "But that does not imply that at this point we know or even have the data to suggest that a routine booster, much less when, would be needed."

But should a booster be needed, Poland expects our most vulnerable populations to receive those first shots.

"I gave the example of a solid organ transplant, that might be true for people receiving certain kinds of chemotherapy agents, the very elderly with a collection of other diseases they might have," Poland said. "That's who I expect that we might first see such a recommendation. For you and I, I think what the concern is that with the seasonal coronaviruses. We know that people become susceptible again and can get re-infected. So by extrapolation, there's been some concern that we may have to periodically give another booster."

Poland added that as long as there are people not vaccinated and COVID-19 variants exist, a variant based booster may be needed.

"It's possible that a new variant could become different enough, from what we've been vaccinated against, that we would need a variant focused booster," Poland said. "But again, all of that is a thought experiment. People are gathering the data and watching. No such recommendation currently."

It may be a while still before any official announcements are made. And if a booster was ever required, there is no indication yet as to how often it would need to be given.

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June 29, 2021 at 06:58AM
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COVID-19 BOOSTER: Mayo Clinic addresses vaccine booster questions - KTTC

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Oxford vaccine produces strong immune response from booster shot - study - Reuters

No evidence yet that booster shots are needed
Antibodies also higher after greatly delayed second dose
Study helps soothe worries over repeat use of viral vector shots

LONDON, June 28 (Reuters) - A third shot of the Oxford-AstraZeneca (AZN.L) COVID-19 vaccine produces a strong immune response, researchers said on Monday, adding there was not yet evidence that such shots were needed, especially given shortages in some countries.

The Oxford University study found that a third dose of the vaccine increases antibody and T-cell immune responses, while the second dose can be delayed up to 45 weeks and also lead to an enhanced immune response.

The British government has said it is looking at plans for an autumn vaccine booster campaign, with three-fifths of adults already having received both doses of a COVID vaccine.

Andrew Pollard, director of the Oxford Vaccine Group, said that evidence that the vaccine protects against current variants for a sustained period of time meant that such a booster may not be needed.

"We do have to be in a position where we could boost if it turned out that was necessary ... (but) we don't have any evidence that that is required," he told reporters.

Vials with AstraZeneca's coronavirus disease (COVID-19) vaccine are seen at the vaccination centre in the Newcastle Eagles Community Arena, in Newcastle upon Tyne, Britain, January 30, 2021. REUTERS/Lee Smith

"At this point with a high level of protection in the UK population and no evidence of that being lost, to give third doses now in the UK whilst other countries have zero doses is not acceptable."

Studies had previously shown that the shot, invented at Oxford University and licensed to AstraZeneca has higher efficacy when the second dose is delayed to 12 weeks instead of four weeks.

Monday's research was released in a preprint, and looked at 30 participants who received a late second dose and 90 who received a third dose, all of whom were under 55.

It helps assuage concerns that viral vector COVID vaccines, such as those made by AstraZeneca and Johnson & Johnson (JNJ.N), may lose their potency if annual inoculations are needed due to the risk that the body produces an immune response against the vectors that deliver the vaccine's genetic information.

"There had been some concerns that we would not be able to use this vaccine in a booster vaccination regime, and that's certainly not what the data is suggesting," study author Teresa Lambe of Oxford's Jenner Institute told Reuters.

Reporting by Alistair Smout; additional reporting by Natalie Thomas Editing by Gareth Jones

Our Standards: The Thomson Reuters Trust Principles.

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June 28, 2021 at 11:48PM
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Oxford vaccine produces strong immune response from booster shot - study - Reuters

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Will We Need Booster Vaccines for Covid-19? Study Raises Doubts. - Barron's

How long the protection from existing vaccines lasts is key to the size of the potential market for booster shots.
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New doubts about the need for booster vaccines against Covid-19 could weaken the case for more gains in shares of companies such as Moderna and BioNTech.

The author of a new study published in the journal Nature on Monday told the New York Times that data he gathered on humoral immune responses in people who had received Pfizer’s Covid-19 vaccine was a “very, very good sign” for the durability of protection provided by messenger RNA-based vaccines.

The bull case for companies that produce those vaccines, including Moderna (ticker: MRNA) and BioNTech (BNTX), is based on the assumption of a reasonably robust market for Covid-19 vaccine booster shots.

The study in Nature, which found high levels of germinal center B cells in the lymph nodes of patients at least 12 weeks after they received their second vaccine dose, could raise questions about how big that booster market will actually be.

While both BioNTech and Moderna have substantial pipelines of drugs under development, many of those programs are in relatively early stages. The financial models of analysts polled by FactSet don’t factor in revenue from any other Moderna product until 2024, or any other BioNTech product until 2023. Those analysts, meanwhile, expect $6.5 billion in Covid-19 vaccine revenues for BioNTech in 2022, and $12 billion for Moderna that year.

The companies remain confident in demand for their Covid-19 vaccines. In an interview with Barron’s published over the weekend, Moderna CEO Stéphane Bancel said that he thinks that the booster market is “even larger” than he thought it was two months ago.

“More than ever, we believe that coronavirus vaccines won’t provide lifelong immunity,” he said.

U.S. health officials, however, have made clear that they have not yet been convinced of the need for booster shots. In a presentation last week, Centers for Disease Control and Prevention officials said that there was “no data to support recommendations for booster,” but that the agency would continue to monitor the evidence.

The article published in Nature early Monday, based on work by scientists at the Washington University School of Medicine and other institutions, examined the effect of messenger RNA-based vaccines on markers of humoral immunity, which could indicate long-lasting protection from the virus. By studying the lymph nodes of patients, the study found surprisingly high levels of what are known as germinal center B cells three months after vaccination.

“Our studies demonstrate that SARS-CoV-2 mRNA-based vaccination of humans induces a persistent [germinal centre] B cell response, enabling the generation of robust humoral immunity,” the study says.

Speaking to the New York Times, the study’s lead author, Dr. Ali Ellebedy, said that the durability of the responses in the germinal center was a good sign for the mRNA-based vaccines offering longer-term protection. “The fact that the reactions continued for almost four months after vaccination — that’s a very, very good sign,” he told the paper.

Another expert consulted by the paper said that only changes in the virus, not waning of immunity, would require a booster.

The spread of virus variants, meanwhile, is raising global concerns, even as restrictions in the U.S. are lifting. Sydney instituted a two-week lockdown as cases of the Delta variant climbed there, and The Wall Street Journal reported that Israel was reinstating some mask requirements after some vaccinated people contracted the Delta variant.

Meanwhile, on Sunday, AstraZeneca (AZN) said that it had begun dosing participants in a Phase 2/3 trial of a new version of its Covid-19 vaccine designed to protect against the Beta variant of the virus, also known as the South African variant.

Moderna shares were up 0.9% early Monday, while BioNTech’s American depositary receipt was down 0.4%. AstraZeneca ’s ADR was flat.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

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June 28, 2021 at 08:03PM
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Will We Need Booster Vaccines for Covid-19? Study Raises Doubts. - Barron's

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University of Pittsburgh School of Medicine in COVID-19 vaccine booster clinical trial - ABC27

PITTSBURGH, Pa. (WHTM) — The University of Pittsburgh School of Medicine is one of the twelve sites across the country selected to participate in a clinical trial in which fully vaccinated adults will receive a third “booster” dose of a COVID-19 vaccine.

The National Institute of Allergy and Infectious Diseases clinical trial will study the safety and immune response of a mixed-booster regimen. The Pittsburgh Vaccine Trials Unit’s study is broken up into two cohorts, according to the press release:

One group will be comprised of fully vaccinated adults who received one of the three COVID-19 vaccines available in the U.S. under FDA Emergency Use Authorization: Johnson & Johnson’s Janssen, Moderna and Pfizer. Twelve to 20 weeks following their initial vaccination regimen, volunteers will receive a single booster dose of another COVID-19 vaccine.
Another group will be comprised of around 250 adults who have not received a COVID-19 vaccine. Volunteers will receive the two-dose Moderna COVID-19 vaccine regimen and will receive a booster dose of a vaccine about 12 to 20 weeks later

“As more and more COVID-19 variants are identified, we need to figure out how we, as a community, can stay protected. The study’s design is not to show whether we need booster shots. Its focus is identifying which vaccine combinations are safe and provide the most protection against the virus that causes COVID-19 and its variants.”

The volunteer will provide blood samples throughout the year, which will be used to study their immune response against new variants. Initial results are expected in late summer 2021.

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June 28, 2021 at 11:08PM
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University of Pittsburgh School of Medicine in COVID-19 vaccine booster clinical trial - ABC27

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COVID-19 booster shots: Will everyone need to get it? | Daily Sabah - Daily Sabah

Amid the massive vaccination campaign across the world, many questions about the immunity against COVID-19 remain unanswered.

The first thing you need to know about COVID-19 booster shots is that nothing about them has been set in stone. There is no guarantee we will need them one day. There is no guarantee we won't.

To make matters murkier, it's also unclear just what a booster shot would have to accomplish, should it become necessary.

If scientists discover that immunity to the coronavirus starts to wane months or years after vaccination, a booster could be deployed to extend that immunity.

If a new variant emerges that is impervious to the immunity offered by our current vaccines, a booster would be required to broaden our protection to include this new foe.

Unfortunately, scientists are already seeing evidence that the immunity provided by our initial vaccines will not last forever.

In a study published Wednesday in the journal ACS Nano, scientists found that people lost an average of 90% of the antibodies they developed within 85 days of receiving the second dose of vaccine.

A similar drop was seen in those who had been infected with the virus.

"It happened to everybody, regardless of circumstances, and it suggests that at some point antibodies will drop to a level where there is not a sufficient amount to be protective," says Dr Otto Yang, an infectious disease specialist at the University of California, Los Angeles, who led the work.

"That's why a booster would be needed."

But before you freak out that your vaccination will become moot three months after you got it, keep in mind that scientists don't know if the attrition of antibodies will continue at the same rate, or what levels of antibodies are needed to provide protection from the virus.

"The vaccines generated a vast excess of antibodies compared to what's needed," Yang says. "Even 10 percent of the original antibody level is probably a lot."

He also cites other studies that have shown vaccines are still offering excellent protection six months after a person was inoculated.

Dr Kawsar Talaat, associate professor of international health at the Johns Hopkins Bloomberg School of Public Health, discusses the state of COVID-19 boosters and how scientists will determine when and if they are needed.

Q: Do you think we're going to need booster shots?

A: We don't have the data yet of how long immunity will last, because the vaccines are so new. But they are really good vaccines and induce a really good immune response, and an even better memory response.

Q: What's a memory response?

A: Some vaccines induce both an immediate immune response and a memory response. When the cells that fight the infection are generated, some become short-lived cells called effector cells that make antibodies, and some become memory cells.

Memory cells live a long time and protect you even after those effector cells are gone. If the virus enters the body, they say, "I know what this is," and spin off and divide to make new effector cells to fight the infection.

Q: What about needing a booster that's targeted to a variant?

A: What we've seen so far is that two doses of vaccine work very well against the (current) variants. Eventually, we could have a variant that the vaccines don't protect against, and then we'd want to make a vaccine for that variant that would be a booster.

But instead of focusing on giving fully vaccinated people additional doses, we should use our vaccines to vaccinate more people and prevent the development of variants.

Q: Why do some vaccines require periodic boosters and others just need one or none?

A: Different vaccines act differently. Some do a better job of creating a memory response than others.

Also, the longevity of the immune response to vaccines varies. Ninety percent of us are protected essentially our whole lives from measles after getting that vaccine. The second dose is not to boost the immune response but instead to capture half of the people who didn't respond to the first vaccine.

On the opposite end, the flu vaccine does not induce a good memory response, so the immune response to the flu vaccine is short-lived. Even if the strains didn't change every year you would need another shot.

Q: How will scientists determine if we do need booster shots for COVID-19?

A: We're going to be looking at the antibody response and memory response of people who participated in the vaccine trials. I volunteered for one of the studies and I go back periodically and they take my blood and measure my antibody response. They'll keep following me for two years and collecting that data.

Q: What about breakthrough cases?

A: We know breakthrough cases do happen, so we'll also be monitoring them to understand who gets them and what variants they have. If we see an uptick of breakthrough cases in populations that are fully vaccinated, that would be cause for concern because either immunity has waned or there is a variant that has escaped.

Q: If we don't even know whether COVID-19 boosters will be needed, why is there so much discussion about them?

A: I don't know!

Some of it is that we have to think about variants and plan ahead for that. And there is some question about whether immunocompromised people or the elderly will need boosters because their immune system is waning.

But mostly, I think there is a lot of concern, but there is no data that says we need to be concerned.

The Link Lonk

June 28, 2021 at 01:02PM
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COVID-19 booster shots: Will everyone need to get it? | Daily Sabah - Daily Sabah

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Health officials talk latest on potential COVID-19 booster shot - WBRC

BIRMINGHAM, Ala. (WBRC) - This week, the CDC acted against recommending COVID-19 booster shots at this time, saying the need and timing has not been established yet. Local health officials say this is a good sign.

Jefferson County Infectious disease expert Dr. Wesley Willeford said the CDC did not recommend a booster right now because they need more data before suggesting an extra shot. He said the only way to get more data is with time.

But, Willeford also said the CDC didn’t recommend the booster right now because the vaccine’s immunity is lasting. He said so far, data shows that both the vaccine and natural Covid immunity last for at least longer than six months. He said that means immunity could last around eight months, but maybe longer.

“I take that as a good thing,” Willeford said. “That it is looking like we are going to go longer than six months and probably closer to a year, which is more in line for things we do with like the flu vaccine. It could be longer, but I think we are at least heading that direction.”

Dr. Willeford said the CDC and drug companies are preparing for the need for boosters just in case, so he does not predict booster availability will be scarce like with the original vaccine.

He also said he doesn’t think there will be as much hesitancy surrounding potential booster shots.

The Link Lonk

June 28, 2021 at 10:26AM
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Health officials talk latest on potential COVID-19 booster shot - WBRC

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AstraZeneca, Oxford Univ tests Covid booster shots against Beta-variant - Business Standard

British-Swedish biopharmaceutical firm AstraZeneca has in partnership with the University of Oxford rolled out human trials for booster shots against Beta Covid variant

Topics
Coronavirus Vaccine | AstraZeneca | Oxford University

IANS | London

Last Updated at June 28, 2021 13:18 IST

British-Swedish biopharmaceutical firm AstraZeneca has in partnership with the University of Oxford rolled out human trials for booster shots against Beta Covid variant.

The booster shot, named AZD2816, will be administered to individuals who have previously been fully vaccinated with two doses of AstraZeneca vaccine/Vaxzervia or an mRNA vaccine, at least three months after their last injection.

In non-vaccinated individuals, AZD2816 will be given as two doses, four or twelve weeks apart, or given as a second dose following a first dose of AstraZeneca vaccine/Vaxzervia --four weeks apart, the company said in a statement on Sunday.

AZD2816 has been designed using the same adenoviral vector platform as AstraZeneca vaccine/ Vaxzervia, with minor genetic alterations to the spike protein based on the Beta (B1351) variant, first identified in South Africa.

The study aims to enroll 2,250 participants from the UK, South Africa, Brazil and Poland to build immunity against the Beta Covid variant.

"Testing booster doses of existing vaccines and new variant vaccines is important to ensure we are best prepared to stay ahead of the pandemic coronavirus, should their use be needed," said Professor Sir Andrew J. Pollard, chief investigator and director of the Oxford Vaccine Group, in the statement.

Initial data from the trial is expected later this year and, once available, will be submitted to regulators for assessment as a next-generation booster vaccine and through an expedited regulatory pathway, the company said.

"The Beta variant vaccine contains 10 changes across the spike protein, many of which are also seen in other variants of concern, and which lead to effects such as, reduced ability of antibodies induced against the original virus to block cell entry (K417N, E484K, N501Y), increased infectivity compared to the original virus (D614G); reduced sensitivity of neutralising antibodies to the original virus (L452R)," the company said.

Besides these minor modifications, the two AZD2816 and AstraZeneca vaccine/ Vaxzervia vaccines are the same, it noted.

In May, the UK launched a clinical trial that aimed to assess the efficacy of a third 'booster' dose of seven different Covid-19 vaccines -- Oxford-AstraZeneca, Pfizer-BioNTech, Moderna, Novavax, Valneva, Janssen and Curevac -- on patients immune responses.

It costs 19.3 million pound and is being funded by the UK government and led by the University Hospital Southampton NHS Foundation Trust.

Meanwhile, the US Centers for Disease Control and Prevention has noted that there is currently no data to support that a Covid-19 vaccine booster shot is needed for the general population. But, an extra dose may be needed for more-vulnerable groups, such as older adults or organ transplant patients.

Both Pfizer and Moderna are investigating a third dose of Covid vaccine, while Johnson & Johnson is studying the need for a second dose to raise protection against the virus, the report said.

The US NIH's National Institute of Allergy and Infectious Disease, or NIAID, is also conducting a clinical trial to understand whether a third shot of a Moderna vaccine could be given after a person initially received two shots of Pfizer, or one shot of Johnson & Johnson, the report added.

--IANS

rvt/in

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Mon, June 28 2021. 13:18 IST

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June 28, 2021 at 02:48PM
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AstraZeneca, Oxford Univ tests Covid booster shots against Beta-variant - Business Standard

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Sunday, June 27, 2021

Booster may be needed for J&J shot as Delta variant spreads - Fox Business

Novavax President and CEO Stanley Erck on its vaccine being 90.4% effective in a clinical trial and why the booster shot will be its' 'biggest market' in the U.S.

NEW YORK -Infectious disease experts are weighing the need for booster shots of the Pfizer/BioNTech or Moderna mRNA-based vaccines for Americans who received Johnson & Johnson's one-dose vaccine due to the increasing prevalence of the more contagious Delta coronavirus variant

FDA ADDS WARNINGS ABOUT RARE HEART INFLAMMATION TO PFIZER, MODERNA COVID VACCINES

Ticker	Security	Last	Change	Change %
JNJ	JOHNSON & JOHNSON	164.21	+0.84	+0.51%
AZN	ASTRAZENECA PLC	59.35	+0.93	+1.59%
PFE	PFIZER INC.	38.98	-0.21	-0.54%

Andy Slavitt, the former senior pandemic advisor to President Joe Biden, raised the idea this week on his podcast. At least half a dozen prominent infectious disease experts said U.S. regulators need to address the issue in short order.

"There's no doubt that the people who receive the J&J vaccine are less protected against disease," than those who get two doses of the other shots, said Stanford professor Dr. Michael Lin. "From the principle of taking easy steps to prevent really bad outcomes, this is really a no brainer."

The CDC is not recommending boosters, and advisors to the agency said at a public meeting this week there is not yet significant evidence of declining protection from the vaccines.

MODERNA WINS $3.3B DEFENSE DEPARTMENT CONTRACT FOR ADDITIONAL COVID-19 VACCINE DOSES

Jason Gallagher, an infectious diseases expert at Temple University’s School of Pharmacy, recently received a Pfizer (NYSE:PFE) dose at the Philadelphia vaccine clinic where he has been administering shots. He got the J&J vaccine in a clinical trial in November.

Gallagher said he was concerned about the UK data showing lower efficacy against the Delta variant for people who received one vaccine dose.

"While the situation has gotten so much better in the U.S., the Delta variant that's spreading ... and really quickly taking over in the U.S. looks a little more concerning in terms of the breakthrough infections with the single-dose vaccines," he said. "So I took the plunge."

Cases, hospitalizations and deaths have plummeted in the United States with 56% of the adult population fully vaccinated.

J&J said it is testing whether the immune response from its vaccine is capable of neutralizing the Delta variant in a laboratory setting, but no data is available yet.

CAN EMPLOYERS MAKE COVID-19 VACCINATION MANDATORY?

Both mRNA vaccines showed efficacy rates around 95% in large U.S. trials, while J&J's vaccine was 66% effective in preventing moderate-to-severe COVID-19 globally when more contagious variants were circulating.

Dr. Angela Rasmussen, a researcher at the University of Saskatchewan's Vaccine and Infectious Disease Organization, said on Twitter she had gotten a dose of Pfizer's vaccine this week after receiving J&J's in April.

Rasmussen, who declined to be interviewed, encouraged Americans who received the J&J vaccine to talk to their doctors about a possible second shot.

"If you live in a community with overall low vaccination, I'd suggest you strongly consider doing so," she tweeted.

Vaccine expert Dr. Peter Hotez from Baylor College of Medicine in a tweet said adding a second J&J dose or one of the mRNA vaccines might provide broader protection, "but we need data and CDC-FDA guidance."

CLICK HERE TO READ MORE ON FOX BUSINESS

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) is running a trial to determine the need for boosting all currently authorized shots with another dose of Moderna's vaccine. NIAID scientist Dr. John Beigel told Reuters the agency hopes to have that data by September to help inform regulators' decisions on boosters.

As long as case counts remain low in the United States, J&J recipients should wait for more data, he said.

If Delta variant-driven infections and hospitalizations increase significantly, he said, "then decisions might need to be made with an absence of data. But right now, I do think it's appropriate that they wait."

The Link Lonk

June 28, 2021 at 01:31AM
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Booster may be needed for J&J shot as Delta variant spreads - Fox Business

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Covid-19 Vaccine Booster Market Keeps Getting Bigger: Moderna CEO - Barron's

When Stéphane Bancel took the reins of Moderna, he had a staff of one and a laptop. A decade later, he is the CEO of an $80 billion company that says it will make up to a billion doses of its Covid-19 vaccine this year. The stock has risen more than 1,300% since the start of 2019.

Born in Marseille, France, Bancel says he didn’t like biology in high school, but fell in love with the “elegance” of biochemistry in college. He received a master’s degree in biochemical engineering from the University of Minnesota and an M.B.A. from Harvard Business School before going to Eli Lilly (ticker: LLY), and then serving as CEO of the diagnostics firm bioMerieux (BMXMF). He started as Moderna’s (MRNA) CEO in July 2011.

We spoke with Bancel, one of Barron’s Top CEOs for 2021, in early June. Here is an edited transcript of that conversation.

Barron’s: When you started at Moderna, where did you think the company would be in 10 years?

Bancel: It’s 10 years in a month.

It was most likely that we would not be commercial 10 years after. I had hoped that we would find a way to make the science work, to have enough drugs in the clinic that we might be, I would say, another three to five years out to commercial [after 10 years].

It moved a little bit faster than that. What has life been like inside of the company over the past year or so?

My wife will tell you: The more pressure he has on his shoulders, the more focused he is.

When we started chasing the virus, I thought it was going to be an outbreak, like MERS or SARS. But the big pivot for me and the company was the week of January 20 at Davos. I’m like oh, it’s going to be a pandemic like 1918.

What was easy for us is, we didn’t have to try to motivate any employees or spend a lot of time explaining what was going on.

The thing that has been most amazing for me, being on the inside, is the level of collaboration, ingenuity. It seems that all of us, the clinical team, manufacturing team, I mean, everybody was really pulling together in a way I’ve never seen. Also collaborators – just the FDA has been amazing. Sometimes two, three meetings in a day. That same process would take two months in a normal drug.

There’s so much attention and so much desire to understand where we were, that we felt a moral obligation to be very transparent, because we were all in this pandemic together as a planet. But that outside scrutiny made us waste a lot of time.

How has your thinking evolved on booster shots? Do you still think that the booster market is as large as we imagined it was two months ago?

Yes. Even larger.

More than ever, we believe that coronavirus vaccines won’t provide lifelong immunity.

The big unknown is the variants, of course. The more [the virus] migrates away from what has been coded into the original vaccines, the lower [the vaccine’s] efficacy is going to be. And you have waning immunity over time.

My mom has leukemia. She was vaccinated in January, as per order of priority in Paris. But do I want her to go spend next fall and winter without the boost, given she’s immunocompromised and 72, and she might get a variant? Yeah, I would like her to be vaccinated [again].

This is the conversation I’ve had with a few health ministers in the past few months.

Immunity is going to wane because of time, and because of variants. So the question is, are we going to be two months too late, or two months too early at boosting? I propose we should rather be two months too early, than two months too late

As long as you have the safety data, two months too early isn’t going to hurt anybody. But two months too late you’re going to have people in hospital and dying, and the economies in lockdown again.

The booster vaccine market seems to be getting a little more crowded with the positive Novavax (NVAX) data. Are you concerned that Moderna could get squeezed between Pfizer (PFE) and Novavax?

A lot of countries last year, when they were purchasing [vaccines] for ’21, got burned because they bought vaccines from companies they thought could have high efficacy and deliver manufacturing. A lot of them learned their lesson the hard way. Europe, as you might know, has said they don’t want to buy any more [AstraZeneca] vaccines in ’22.

2022 sales are happening right now. [On Moderna’s first-quarter earnings call I said] we are talking to all recurrent countries that signed up for ’21, for ’22, because we have to do the kids and boosting, of course. And there’s a lot of countries that never signed for Moderna vaccine in ’21 that want mRNA vaccines.

If you are health minister in, pick a country you like, you have to make a decision soon, because if you don’t decide soon for Moderna, I’m telling you, you won’t get product in the first quarter [of 2022]. The first quarter is almost full.

People aren’t appreciating is that 2022 sales are happening right now. Even at 10 bucks, if you need 20 million doses, that’s $20 million. That is not pocket change for medium [sized] countries or governments. And so, do you buy a vaccine that you know is going to work, from a company that’s been reliably delivering to you doses?

That’s the piece about Moderna that a lot of people don’t appreciate. Look at the issues [ AstraZeneca ] has had in Europe or [ Johnson & Johnson ] has had in the U.S. We have delivered, manufacturing-wise.

Can I ask you one more thing? Where do you think the virus came from?

The hypothesis of a leak from Wuhan, I think it’s possible. Because humans make mistakes. The theory that it was leaked on purpose, I believe is a very low probability.

Could it be a human mistake done in a Wuhan lab where somebody then went home and infected, without knowing, their family…and then it looked like flulike symptom and they’re just sick at home? That’s highly possible. I am incapable of handicapping it from a probability standpoint, versus coming from an animal at the Wuhan market. It’s impossible to put a probability on that scenario.

Thanks, Stéphane.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

The Link Lonk

June 27, 2021 at 05:00PM
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Covid-19 Vaccine Booster Market Keeps Getting Bigger: Moderna CEO - Barron's

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Coronavirus vaccine: These people will need COVID-19 booster shots soon - Deseret News

The World Health Organization has said the most vulnerable will need COVID-19 booster shots every year to avoid the coronavirus variants, according to WHO internal documents obtained by Reuters.

The new WHO documents — which will be discussed in an upcoming meeting — suggest that annual boosters for high-risk individuals will be “indicative” of a normal scenario. The general population will likely need boosters every two years, according to Reuters.

“It does not say how these conclusions were reached, but shows that under the base scenario new variants would continue to emerge and vaccines would be regularly updated to meet these threats,” Reuters reported.

The WHO said the report is a work in progress and the forecast could change with time.

Interestingly, details of the report come days after a group working with the Centers for Disease Control and Prevention said there’s no immediate evidence that COVID-19 boosters are necessary.

However, the group said there could be a need down the road, NBC News reports. And officials need to figure out whether unvaccinated people need boosters or if the world should offer boosters/shots to unvaccinated people first or fully vaccinated people, as I wrote for the Deseret News.

“Prior to going around and giving everyone boosters, we need to improve the overall vaccination rate,” said Dr. Keipp Talbot, an associate professor of medicine at Vanderbilt University, according to NBC News.

The Link Lonk

June 26, 2021 at 09:00PM
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Coronavirus vaccine: These people will need COVID-19 booster shots soon - Deseret News

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Saturday, June 26, 2021

Will we need a COVID vaccine booster? Fall unlikely, but spring a possibility - National Post

Canada has millions of extra COVID shots on order, but should we save those for third doses, or help the world’s poorest countries get their first one?

Author of the article:

Sharon Kirkey

Publishing date:

Jun 26, 2021 • 2 hours ago • 5 minute read • 11 Comments

The World Health Organization estimates COVID-19 boosters will be needed yearly for the most vulnerable, and every two years for the general population, according to an internal document seen by Reuters. Meanwhile, Canada has committed up to $1 billion to buy more doses. Photo by Paul Chiasson/The Canadian Press

With the provinces still hurrying to get second COVID vaccine doses into bodies, it seems odd to be talking boosters, third doses. Can’t we just celebrate this moment, of “sustained national decline” in COVID and glorious reopenings, and catch our breath?

Most Canadians have been, or will be, getting second dosed from May through July, and published data suggest “very little drop off” in antibody levels by several months out, said University of Toronto immunologist Tania Watts. Unlike the United Kingdom, which, according to the BBC, is planning for an autumn “booster jab” rollout, Watts very much doubts the Canadian general public would need a third dose in the fall.

Beyond that, the situation gets murky. “If we need it, could it be as early as next spring? Possibly,” she said. Two or three years? Again, possibly. These are new vaccines and a new virus and it’s hard to predict. But assuming immunity will, at some point, wane, “I think there has to be an option to be ready to roll out the vaccine again,” Watts said.

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