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Tuesday, June 29, 2021

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


Coronavirus

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.

RELATED: First Moderna, now Pfizer-BioNTech working on booster shot amid rise of COVID-19 variants

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.

RELATED: Pfizer expects higher COVID-19 vaccine prices and yearly boosters, CFO says. And that means big sales long-term

“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.

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

Coronavirus by: Reuters , via Nexstar Media Wire Posted: Jun 29, 2021 / 02:02 PM EDT / Updated: Jun 29, 2021 / 02:02 PM EDT THORN...

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