Moderna to study vaccine booster aimed at coronavirus variant - BioPharma Dive

Dive Brief:

• Moderna on Monday said its vaccine for COVID-19 should still protect against coronavirus variants first detected in the U.K. and in South Africa, citing results from laboratory testing that showed the blood of immunized volunteers in an early study contained antibodies capable of neutralizing the virus. 
• Even so, the Cambridge, Massachusetts-based biotech plans to study whether an additional booster shot, or a new booster engineered specifically against the South African variant, could provide better protection. 
• Vaccine and public health experts have grown more concerned that accumulating mutations in the spike protein targeted by many of the shots authorized and in testing could help the coronavirus evade vaccination. So far, however, evidence indicates the available vaccines, which generate multifaceted immune responses, should still be effective. 

Dive Insight:

One of the chief advantages of the messenger RNA vaccine technology used by Moderna as well as Pifzer and BioNTech is the ease by which it can be adapted. 

At the core of mRNA vaccines is a nucleic acid sequence encoding for a target viral protein, like the coronavirus' characteristic spike. In the case of Moderna's shot, determining the right sequence took researchers at Moderna and the U.S. National Institutes of Health just two days after Chinese researchers first posted the coronavirus genome online. A Phase 1 clinical trial followed roughly 60 days later. 

In theory, updating an mRNA vaccine to address new mutations in the target protein should require only tweaks to that sequence, and subsequent testing to ensure the encoded protein still reliably raises a protective immune response. 

Moderna's announcement Monday that it will proceed with studies of a re-engineered booster shot is suggestive of the speed at which that first step can be carried out. The company said it would advance the new strain-specific booster into preclinical testing and a Phase 1 study in the U.S. 

Company CEO Stéphane Bancel said the decision was made "out of an abundance of caution" following laboratory testing on the two variants. Using blood samples from eight volunteers vaccinated with its shot in an early study, Moderna measured the levels of neutralizing antibodies for the variants originating in the U.K. and South Africa, dubbed B.1.1.7 and B.1.351, respectively. 

Emerging data have shown both variants appear to be more infectious, although it's not certain whether they also are more deadly. 

In tests against the U.K. variant, there was no significant impact to neutralizing antibody levels compared with prior variants, Moderna said. 

Against the South African variant, however, neutralizing antibody levels were six-fold lower. Based on data from testing in monkeys, Moderna believes its shot will still protect people infected with that variant against COVID-19. But the company noted the lower antibody levels "may suggest a potential risk of earlier waning of immunity to the new B.1.351 strains."

A draft manuscript detailing Moderna's findings was posted on the pre-print server bioRxiv Monday. 

Pfizer and BioNtech's vaccine, which was shown similarly effective to Moderna's in late-stage trials, also proved effective against the U.K. variant in laboratory tests, the companies said last week. 

While mRNA vaccines may prove readily adaptable, scientists are still unsure exactly what levels of antibodies are needed for full protection, potentially complicating efforts to prove updated boosters to regulators. 

Peter Marks, the FDA's top official tasked with reviewing vaccines, recently suggested in an interview with WebMD that replicating the large, time-consuming Phase 3 trials initially used to prove vaccine efficacy may not be needed again. 

"[T]he first time we do it, we will check immunogenicity," Marks said in the Dec. 29 interview. "But it is not going to have to be another 30,000 patient clinical trial. Those immunogenicity studies are usually 400 patients, just to make sure that we have the right check of what's coming out." 

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January 25, 2021 at 11:57PM
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Moderna to study vaccine booster aimed at coronavirus variant - BioPharma Dive

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Florida Vaccine Updates: Miami-Dade Seniors Getting Booster Shots, Frustration Over Long Waits at Sites - NBC 6 South Florida

As a limited supply of the coronavirus vaccine has become available across Florida, residents are understandably anxious to know when they will be able to stand in line for a dose.

Seniors in one South Florida county will now begin to get their booster shots in an effort to continue the vaccination process while some are growing frustrated with the long waits that sometimes end with them not even getting the vaccine.

Here's what we know today about the coronavirus outbreak in Florida, and the effort to stop it.

Miami-Dade Begins Scheduling Appointments for Vaccinated Seniors to Receive Second Shots

Miami-Dade Mayor Daniella Levine Cava delivered an update on the county's vaccination program Saturday, noting that officials have begun scheduling appointments for seniors to get their booster shot.

"Everyone who received a vaccine from a Miami-Dade County site will be contacted to scheduled their second dose directly by email or text," the mayor said in a press release.

Those who can not be contacted by email will be reached by phone, the press release said. The CDC card that patients received at their initial appointment contains the date of when the second shot should be scheduled.

Cava added the county is currently following guidelines regarding masks being worn on public transportation and that the facial covering remain mandatory:

Miami-Dade #COVID guidelines already require masks in public including on public transit. Especially as Florida faces the threat of a new, more contagious variant, it’s more critical than ever that we follow public health precautions to protect our community. #MaskUpMiami https://t.co/QTvBBg78Cr

— Daniella Levine Cava (@MayorDaniella) January 30, 2021

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Florida Adds 15,019 New COVID-19 Cases, Reports 110 More Virus Deaths Saturday

Florida reported just over 15,000 new COVID-19 cases Saturday, as the state's virus-related death toll increased by more than 100.

The 15,019 new confirmed COVID-19 cases brought Florida's total to 1,713,589 since the outbreak began, according to figures released by the state's Department of Health.

The positivity rate for new cases in the state dropped to 6.62% in Saturday's department of health coronavirus report, after reaching 14.46% on Friday.

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Woman Frustrated After Long Wait at Hard Rock Stadium Site Ends With No Vaccine

Carole Goldberg says she was sent back home after waiting three and a half hours in line at Hard Rock Stadium on Friday. 

The 75-year-old got her first COVID vaccine shot on January 8th.  She then got a card telling her to come back for her second shot on the 29th.  She says she was told the card was her confirmation. But, she says when she finally got close enough to check in, she was told she didn’t have an appointment. 

Goldberg is one of many who waited in long lines which wrapped around the stadium only to be sent away. On Friday, the state launched a new pre-registration system for seniors hoping to better organize and streamline the process. 

Stay on top of the latest news and weather. Download the NBC 6 app for 

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January 31, 2021 at 09:00PM
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Florida Vaccine Updates: Miami-Dade Seniors Getting Booster Shots, Frustration Over Long Waits at Sites - NBC 6 South Florida

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Florida Vaccine Updates: Miami-Dade Begins Scheduling Booster Shots for Seniors - NBC 6 South Florida

As a limited supply of the coronavirus vaccine has become available across Florida, residents are understandably anxious to know when they will be able to stand in line for a dose.

A new program was recently launched across the state in an effort to help with the registration process for the vaccine while some local hotels in South Florida will begin offering testing to those coming to the area looking for some fun in the sun.

Here's what we know today about the coronavirus outbreak in Florida, and the effort to stop it.

Miami-Dade County Begins Scheduling Appointments for Vaccinated Seniors to Receive Second Shots

Miami-Dade Mayor Daniella Levine Cava delivered an update on the county's vaccination program Saturday, noting that officials have begun scheduling appointments for seniors to get their booster shot.

"Everyone who received a vaccine from a Miami-Dade County site will be contacted to scheduled their second dose directly by email or text," the mayor said in a press release.

"We are working hard to get shots in arms as fast as possible, including reaching out directly to everyone who received their first vaccine from the county to get their second shot and complete the vaccination process." 

Those who can not be contacted by email will be reached by phone, the press release said. The CDC card that patients received at their initial appointment contains the date of when the second shot should be scheduled.

Florida Launches Statewide Preregistration System for COVID Vaccine Appointments

Florida has launched a statewide preregistration system to help frontline health workers and seniors schedule COVID-19 vaccination appointments.

The system allows people to pre-register to receive the vaccine and be notified when appointments are available at state-supported vaccination sites. The website to preregister is myvaccine.fl.gov.

On the site, residents can select their county and submit their contact information. Once appointments are available, individuals will be contacted by phone call, text or email and will be assisted in scheduling an appointment.

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As Virus Mutates, Promising Vaccine Races Against Time

As vaccine supplies remain low, Johnson & Johnson Friday announced a new candidate is showing promising results and the single-dose shot could be in arms by the end of next month, if approved by the Food and Drug Administration.

Johnson & Johnson reported its vaccine is 72% effective in the U.S. in preventing moderate to severe COVID. That drops to 66% overall because it was only 57% effective among trial participants in South Africa, where the troublesome mutant is prevalent.

Leading infectious disease expert Dr. Anthony Fauci said vaccine manufacturers will need to be nimble in adjusting their products as new strains arise, as they inevitably will if the virus continues to spread.

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‘You Wouldn't Know There Was a Pandemic': People Seen Without Masks, Not Following COVID-19 Guidelines in Miami-Dade

With spring break just a few months away, a local commissioner and other residents are worried that some South Florida businesses and customers are not following proper COVID-19 safety protocols.

NBC 6 has received complaints saying that people are not wearing face masks or social distancing at restaurants in Surfside and Wynwood, despite a mask mandate issued by Miami-Dade County.

From December 8th to January 24th, the Surfside Police Department said it had 25,000 verbal mask warnings on record and have also handed out 175 masks.

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Local Hotels to Offer COVID-19 Testing for Guests, Employees

There’s an extra level of comfort being offered for travelers in South Florida. 

After the CDC implemented a new requirement to test negative for COVID-19 before entering the U.S., some South Florida hotels are offering testing as well.

When making a reservation at SLS South Beach, future guests will get the option to take a COVID-19 test at the property. Marco Selva, the Area Vice President for SLS Brickell, told NBC 6 the hotel’s parent company wants to be proactive and offer more testing during a person’s stay. For them, on-site PCR or rapid antigen tests are available. Employees can get tested every day. 

Stay on top of the latest news and weather. Download the NBC 6 app for 

iOS or Android.

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January 30, 2021 at 11:19PM
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Florida Vaccine Updates: Miami-Dade Begins Scheduling Booster Shots for Seniors - NBC 6 South Florida

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Brooks Place residents get COVID booster - Winchester Sun - Winchester Sun

RANDY PATRICK

Sun Reporter

Residents of Rose Mary C. Brooks Place got their booster shots Friday to protect them against COVID-19.

The second round of the Pfizer vaccinations was given by Walgreens employees.

Tim Janes, executive director of the assisted living home on Bypass Road said that about 95 percent of the residents volunteered to take the vaccine.

“I’m happy with that number,” he said.

He said there were about three people who had their first shot, and they will get their booster after the appropriate waiting time, which is about 20 days.

About Randy Patrick

Randy Patrick is a reporter for Bluegrass Newsmedia, which includes The Jessamine Journal. He may be reached at 859-759-0015 or by email at randy.patrick@bluegrassnewsmedia.com.

More by Randy

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January 31, 2021 at 05:52AM
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Brooks Place residents get COVID booster - Winchester Sun - Winchester Sun

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COVID Vaccine Updates: Boosters for South African variant in the works - WABC-TV

NEW YORK (WABC) -- Officials have confirmed the first cases of a highly contagious South African variant of COVID in the United States.

Two people, who have no connections to each other or a history of travel, were infected in South Carolina.

Early tests showed the South African variant may chip away at the effectiveness of the Pfizer and Moderna vaccines. Both are now working on a booster shot.

And now, the CDC is urging Americans to avoid travel. President Biden added South Africa to the list of countries banned from traveling to the US, although the ban that doesn't take effect until Saturday.

What to know about coronavirus:
Tracking COVID-19 availability and progress in NYC
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Find out if you are eligible and where you can go to get your vaccine
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Do you have coronavirus symptoms?

Here are more of today's headlines:

Cuomo announces mass vaccination site at Yankee Stadium is in development

Governor Cuomo announced a mass vaccination site is in the works at Yankee Stadium. With a Bronx positivity rate currently at 7.6 percent, the site will be reserved for Bronx residents.

Canada COVID restrictions: Mandatory travel quarantine, flights south suspended in response to new variant
Prime Minister Justin Trudeau on Friday announced stricter restrictions on travelers in response to new, likely more contagious variants of the novel coronavirus - including making it mandatory for travelers to quarantine in a hotel at their own expense when they arrive in Canada and suspending airline service to Mexico and all Caribbean destinations until April 30. Trudeau said in addition to the pre-boarding test Canada already requires, the government will be introducing mandatory PCR testing at the airport for people returning to Canada.

NJ has now administered more vaccines than the state's total number of positive test results
New Jersey has now administered more COVID-19 vaccinations than the state's total number of confirmed and presumed positive test results, Gov. Phil Murphy announced Friday. The state has put 724,371 shots in arms while the state has reported 687,269 total positive PCR and antigen test results.

Cardinal Dolan in quarantine
Cardinal Timothy Dolan has cancelled all public appearances, including celebrating 10:15 a.m. Sunday Mass at St. Patrick's Cathedral, to remain in quarantine after last week having been in close contact with an individual who has tested positive for COVID-19. Church officials say Dolan has not tested positive, feels fine, and has no symptoms. He will, however, continue to follow health and safety protocols as instructed by medical professionals, as will others on his staff who also had close contact with this individual.

NYC indoor dining to resume on Valentine's Day, Cuomo says
Indoor dining will be allowed to resume in New York City on Valentine's Day, Gov. Andrew Cuomo announced Friday. Restaurants in the city will be allowed to open their doors to diners at 25 percent of capacity. Restaurants in other parts of the state have already been allowed to open indoor dining at 50 percent capacity.

Weddings can resume in New York
Governor Cuomo says weddings can restart on March 15 at 50% capacity of the venue or up to 150 patrons. Testing all patrons attending the event will be required. Local health departments will approve.

Johnson & Johnson single-shot vaccine 85% effective against severe COVID-19 disease
Johnson & Johnson's long-awaited vaccine appears to protect against COVID-19 with just one shot - not as strong as some two-shot rivals but still potentially helpful for a world in dire need of more doses. J&J said Friday that in the U.S. and seven other countries, the single-shot vaccine was 66% effective overall at preventing moderate to severe illness, and much more protective - 85% - against the most serious symptoms. There was some geographic variation. The vaccine worked better in the U.S. - 72% effective against moderate to severe COVID-19 - compared to 57% in South Africa, where it was up against an easier-to-spread mutated virus.

Cuomo deals with fallout from nursing home response report
New York Gov. Andrew Cuomo's administration confirmed Thursday that thousands more nursing home residents died of COVID-19 than the state's official tallies had previously acknowledged, dealing a potential blow to his image as a pandemic hero. The surprise development, after months of the state refusing to divulge its true numbers, showed that at least 12,743 long-term care residents died of the virus as of Jan. 19, far greater than the official tally of 8,505 on that day, cementing New York's toll as one of the highest in the nation. Those numbers are consistent with a report released just hours earlier by state Attorney General Letitia James charging that the nursing home death count could be off by about 50%, largely because New York is one of the only states to count just those who died on facility grounds, not those who later died in the hospital.

Pandemic triggers a Grape-Nuts cereal shortage
If you're having a hard time finding Grape-Nuts at your local supermarket, you are not alone. The pandemic has come for Grape-Nuts. Supply chain constraints and higher demand for cereal have led to shortages of the product, Kristin DeRock, Grape-Nuts Brand Manager, said in an emailed statement. Grape-Nuts should be "fully back" on shelves in the spring, she said.

4-year-old home from hospital after COVID-19 leaves her paralyzed
A 4-year-old girl is paralyzed after she was diagnosed with Acute Transverse Myelitis as a result of COVID-19, the girl's mother tells KOAT.

KOAT spoke to 4-year-old Stella Martin and her mother, Cassandra Yazzie, a day after Stella was finally released from the hospital after an 8-month long hospitalization.

Top 7 COVID vaccine questions answered
You had questions about COVID-19 vaccines and 7 On Your Side is getting you answers from doctors on the front line of the pandemic.

MORE CORONAVIRUS COVID-19 COVERAGE

Positive COVID-19 cases by zip code - New York City

A 4-year-old girl is paralyzed after she was diagnosed with Acute Transverse Myelitis as a result of COVID-19, the girl's mother tells KOAT.
New York City COVID-19 Vaccine Tracker
New Jersey COVID-19 Vaccine Tracker
Find out if you are eligible and where you can go to get your vaccine
Do you have coronavirus symptoms?
Where to get tested in New York, New Jersey and Connecticut
WATCH: Eyewitness to a Pandemic
Centers for Disease Control and Prevention on coronavirus

Submit a News Tip or Question

Copyright © 2021 WABC-TV. All Rights Reserved.

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January 30, 2021 at 09:00AM
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COVID Vaccine Updates: Boosters for South African variant in the works - WABC-TV

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Opinion | Get One Covid Vaccine Dose to Everyone Most Likely to Die - The New York Times

Even in non-pandemic times, the public health authorities of certain countries, notably Britain, have sometimes deviated from vaccine schedules tested in clinical trials without conducting additional trials.

Take the vaccine for seasonal influenza. The schedule endorsed by the American Academy of Pediatrics calls for two doses to be given four weeks apart to children between six months old and eight years old the first time they are inoculated. But the health authorities in Britain have decided — and without first formally testing this out in a trial — to forgo the booster dose for most two- to nine-year-olds, in order to get available vaccines out to more children.

The strategy has paid off. During the 2016-17 influenza season, the overall effectiveness of the vaccine programs in the United States and Britain was about the same (or 40 percent).

Similarly with the pneumococcal conjugate vaccine. In the United States, it is administered in three injections during the first year of life followed by a booster at age one; this is the so-called 3+1 schedule. Many European countries have dropped one of the first three doses (that’s the 2+1 schedule) — and with no apparent reduction in protection. The World Health Organization has endorsed administering a total of just three shots (whether 2+1 or 3+0).

There is evidence today that something similar could be true with Covid-19 vaccines. In both the Pfizer-BioNTech and Moderna Phase 3 trials, the first dose achieved at least 89 percent efficacy starting two weeks after immunization. Preliminary data from Israel’s mass inoculation campaign suggest likewise, with significant protection against infection reported in the first 430,000 individuals who received an initial shot.

As the F.D.A. points out, estimates of efficacy rates after the first dose in clinical trials are based on a short period of observation: Most participants receive their second dose just three or four weeks later. In theory, delaying the second doses could mean that whatever immunity individuals acquired after the first shot would wane in the interim. Yet typically — as with the vaccines against meningococcus, influenza or typhoid — if immunity following a single dose wanes at all, it does so over months or years, not in a matter of weeks. Just one dose can buy a lot of time.

The Biden administration’s by-the-book approach to Covid-19 vaccination — two shots and delivered, as much as is possible, according to the schedule set by manufacturers — may be the safest for policymakers, but it isn’t the safest for the public. It’s overly prudent, and at this stage of the pandemic, the excess of caution is killing people.

More lives could be saved if we simply forgot about boosters and more trials for a while and rushed right now to give just one shot to all the people who are most immediately at risk of dying.

Adam Finn (@adamhfinn) is a senior clinician in the pediatric immunology and infectious diseases clinical service at Bristol Royal Hospital for Children and a professor of pediatrics at the University of Bristol. Richard Malley (@rickmalley) is a physician specializing in infectious diseases at Boston Children’s Hospital and a professor of pediatrics at Harvard Medical School.

The Times is committed to publishing a diversity of letters to the editor. We’d like to hear what you think about this or any of our articles. Here are some tips. And here’s our email: letters@nytimes.com.

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January 29, 2021 at 05:00PM
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Opinion | Get One Covid Vaccine Dose to Everyone Most Likely to Die - The New York Times

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Will COVID vaccines need a booster shot to combat variants? Here’s what to know - Merced Sun-Star

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1. Will COVID vaccines need a booster shot to combat variants? Here’s what to know  Merced Sun-Star
2. Moderna to study vaccine booster aimed at coronavirus variant  BioPharma Dive
3. First Moderna, now Pfizer-BioNTech working on booster shot amid rise of COVID-19 variants  FiercePharma
4. Moderna To Test Booster Shots To Protect Against New Strains  Kaiser Health News
5. Moderna Developing Vaccine Booster Shot for Virus Strain Identified in South Africa  The Wall Street Journal
6. View Full Coverage on Google News

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January 28, 2021 at 04:29AM
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Will COVID vaccines need a booster shot to combat variants? Here’s what to know - Merced Sun-Star

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Coronavirus weekly need-to-know: Booster shot, pain relievers, eye injuries & more - Miami Herald

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January 29, 2021 at 07:54PM
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Coronavirus weekly need-to-know: Booster shot, pain relievers, eye injuries & more - Miami Herald

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Recommended reopening date for JCPS will depend on vaccine booster supply, Pollio says - WDRB

LOUISVILLE, Ky. (WDRB) – Exactly when Jefferson County Public Schools Superintendent Marty Pollio will recommend reopening classrooms in Kentucky’s largest school district will depend on how many COVID-19 vaccine boosters can be secured for teachers and staff, he told reporters Friday.

JCPS elementary school teachers and staff who registered for COVID-19 vaccinations received their initial doses by Thursday at Louisville Metro’s Broadbent Arena drive-thru site, with the district’s middle and high school personnel slated to begin their vaccination schedules next week, Pollio said.

Central office staff who do not work inside schools will get their first vaccine doses afterward, and Pollio said that’s when he is slated for his initial COVID-19 vaccination.

About 6,600 JCPS teachers and staff have already received their first COVID-19 vaccine shots, and more than 13,000 district employees have signed up for vaccinations.

Classrooms at JCPS have been closed since mid-March, but Pollio and others have seen COVID-19 vaccinations for teachers and staff as a way to resume in-person instruction. About 60% of JCPS families are expected to send their children back to schools once they reopen based on districtwide survey results.

“We have a real, strong chance of coming back to school, and we’re really proud of that and look forward to bringing that plan to our board members over the next couple of weeks,” he said.

The Jefferson County Board of Education will ultimately decide whether and when district classrooms can reopen for in-person instruction, and Pollio said he will offer his recommendation either at the board’s Feb. 16 meeting or at a special meeting.

The school board is scheduled to talk Tuesday with state and local health officials about the COVID-19 pandemic, vaccinations and other issues.

The exact timing of his recommended start date will depend on how many booster vaccine doses are allotted for JCPS, Pollio said. District staff are expected to begin getting their vaccine boosters Feb. 19, he said.

“Once we know that we are getting that from the federal government in collaboration with our health department, then we can lay out that plan,” he said.

Details of how the district will need to operate if classrooms reopen are also unknown. Gov. Andy Beshear said last week that he will relax the state’s color-coded guidance for school operations based on local COVID-19 transmission data, a point Pollio noted Friday.

“We’re anxiously awaiting what those will be,” he said, adding that he may recommend in-person learning at elementary schools five days a week while middle and high schools operate on hybrid schedules.

One JCPS board member has raised doubts about whether the district can safely reopen classrooms during the COVID-19 pandemic.

Chris Kolb, the board’s vice chairperson who represents District 2, said in a post on his campaign website that reopening schools would be problematic and lead to more COVID-19 cases and deaths based on Jefferson County’s persistently high incidence and testing positivity rates.

Kolb was one of two school board members to vote against resuming winter sports competition at JCPS.

“The current evidence and data, however, lead me to the conclusion that it is simply not safe, wise, or responsible to return to competitive winter sports or in-person instruction until everyone in the community has had the opportunity to be vaccinated, until the positive test rate is five percent or less for two weeks, or until Jefferson County is in the “orange” for two weeks and cases in Louisville are steady or declining,” Kolb said in the post.

For Pollio, disagreements at the school board level are similar to the varied COVID-19 views locally and nationwide. Board members, he said, are concerned about the “safety and health of our students and staff.”

“These aren’t easy decisions to make,” he said. “… I know they’ll make the best decision for our kids at that point, and that’s what they’re all committed to doing.”

Copyright 2021 WDRB Media. All Rights Reserved.

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January 29, 2021 at 11:25PM
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Recommended reopening date for JCPS will depend on vaccine booster supply, Pollio says - WDRB

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Why it takes 2 shots to make mRNA vaccines do their antibody-creating best – and what the data shows on delaying the booster dose - The Conversation US

With the U.S. facing vaccination delays because of worker shortages and distribution problems, federal health officials now say it’s OK to push back the second dose of the two-part vaccine by as much as six weeks.

As an infectious disease doctor, I’ve been fielding a lot of questions from my patients as well as my friends and family about whether the COVID-19 vaccine will still work if people are late receiving their second dose.

Why you need two doses 3-4 weeks apart

Two doses, separated by three to four weeks, is the tried-and-true approach to generate an effective immune response through vaccination, not just for COVID but for hepatitis A and B and other diseases as well.

The first dose primes the immune system and introduces the body to the germ of interest. This allows the immune system to prepare its defense. The second dose, or booster, provides the opportunity for the immune system to ramp up the quality and quantity of the antibodies used to fight the virus.

In the case of the Pfizer and Moderna COVID-19 vaccines, the second dose increases the protection afforded by the vaccine from 60% to approximately 95%.

Why the CDC decided receiving the second dose within 42 days is OK

In the clinical trial, the second dose of the Pfizer vaccine was administered as early as day 19 and as late as day 42 to 93% of the subjects. Since protection was approximately 95% for everyone who was vaccinated within this time “window,” there is little reason not to allow some flexibility in the timing of the second dose 2.

As more vaccine becomes available, the timing of the second dose should be close to four weeks for the Pfizer and Moderna vaccines. But the good news is that even while supplies remain limited, the science suggests that there’s nothing bad about getting a second dose as late as 42 days after the first.

What the immune system does between the first and second dose

The biology through which the mRNA vaccines induce their protection from COVID-19 is fundamentally different from that with other vaccines.

Pfizer and Moderna vaccines use messenger RNA that encodes the spike glycoprotein. Upon injection of the vaccine, the mRNA enters into immune cells called dendritic cells. The dendritic cells use the instructions written in the mRNA to synthesize the hallmark spike glycoprotein, which characterizes the SARS-CoV-2 virus that causes COVID-19. These immune cells then show the spike glycoprotein to B-cells, which then make anti-spike antibodies.

Dendritic cells recognize viruses and present information about the spike protein to T-cells. T-cells provide information about the viral spike protein to B-cells, which are transformed to memory B-cells that store information about the virus. When this memory B-cell is activated with an infection or the second dose of the vaccine, this causes some of the B-cells to change into plasma B-cells that secrete protective antibodies that fight the virus. Kateryna Kon/Science Photo Library via Getty Images

The mRNA vaccines are uniquely capable of inducing a special kind of immune cell – called a T-follicular helper cell – to help B-cells produce antibodies. The T-cells do this through direct contact with the B-cells and by sending chemical signals that tell the B-cells to produce antibodies. It is this help in antibody production that makes these vaccines so effective.

But not all B-cells are the same. There are two kinds that make anti-spike antibodies: long-lived plasma cells and memory B-cells. The long-lived plasma cells, as their name implies, live in the bone marrow for years after vaccination, continuously churning out antibody – in this case anti-spike antibody. These long-lived B-cells do not need to be boosted.

The memory B-cells, on the other hand, live in a state akin to hibernation. They do not produce antibodies until stimulated by a booster of the vaccine, or are exposed to infection with the coronavirus that causes COVID-19. That is the reason we need that second dose. Together these two types of B-cells provide a constant level of protection.

What happens if you don’t get the Pfizer or Moderna second dose on time?

With current vaccine shortages, and problems with setting up the infrastructure to vaccinate millions of people, many physicians are concerned that the second dose of vaccine won’t be delivered in the prescribed three-to-four-week window.

That booster shot is necessary for the T-cells to stimulate the memory B-cells to produce massive quantities of antibodies. If the booster isn’t given within the appropriate window, lower quantities of antibodies will be produced that may not provide as powerful protection from the virus.

[Deep knowledge, daily. Sign up for The Conversation’s newsletter.]

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January 28, 2021 at 08:28PM
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Why it takes 2 shots to make mRNA vaccines do their antibody-creating best – and what the data shows on delaying the booster dose - The Conversation US

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Extra vaccine appointments being added for Tulsa County with release of some booster doses - Tulsa World

Patsy and Rick Matsin wait in line Jan. 18 to get COVID-19 vaccines through the Tulsa Health Department. Those who received their first-dose vaccines at a Tulsa County site have been instructed they can return to the same site at least three weeks later, for Pfizer prime doses, or four weeks later for Moderna, to get booster shots.

Mike Simons, Tulsa World file

From Staff Reports

Update: 8,811 new first-dose appointments were added Wednesday night, according to Tulsa Health Department, compared to 5,480 appointments added last Wednesday night.

About 5,000 of those appointments were gone within about two hours, according to a server expert trying to work with the state on technical issues related to the portal. By about 1 a.m., all the appointments were gone, he said. 

Starting Wednesday night, a higher than expected number of vaccination appointments were to be available in Tulsa County because doses that had been held in reserve for booster shots were released early.

The Tulsa Health Department announced the change in a news release Wednesday. Executive Director Bruce Dart said the state requested all counties “burn” through all doses of the vaccine weekly, though shipments had been differentiated between prime and boost doses.

“We are now pivoting to release half of the second-dose inventory on hand as prime doses to add additional appointments,” Dart said in the release. He noted the additional appointments would allow for more Tulsa County providers to be brought in to administer vaccines.

Those who received their first-dose vaccines at a Tulsa County site have been instructed they can return to the same site at least three weeks later, for Pfizer prime doses, or four weeks later for Moderna, to get booster shots.

“Our primary goal is to protect residents with the vaccine, and we know the completed series offers that full protection,” Dart said. The Tulsa Health Department’s release notes that officials have been assured of more shipments from the state to get everyone’s second dose covered.

Oklahoma Deputy Health Commissioner Keith Reed said Wednesday that Tulsa County sites “were holding more of the second doses than we prefer.” The procedural change to release half of the booster shots, about which he said his staff had been in communication with Dart, resolves the state’s concerns.

Reed said he had heard many Tulsa-area residents have had to look outside the area served by Tulsa Health Department for vaccinations, and “more appointments is obviously one of the best fixes.”

“We want to ... slow down this traveling that we’re seeing among the population,” he said.

About 30% of Oklahomans 65 or older have gotten at least one vaccination dose, including those in long-term care centers, Reed said Wednesday.

He said “that’s not enough right now” to consider opening up appointments to the next priority group: younger Oklahomans with comorbidities. Those individuals might be able to more quickly snap up appointments due to more comfort with the requirements of the online portal, Reed said.

“The use of technology to assist with scheduling is not necessarily the best match for this (65 and older) age group, and I feel like it would be very unfair to this group for us to too quickly bring on another group and bring on unfair competition for these appointments,” he said.

Last Wednesday night, Tulsa Health Department added 5,480 appointments to the state portal, according to Operations Section Chief Alicia Etgen. Spokeswoman Leanne Stephens said the number of booster doses to be released for first-dose appointments wasn’t available Wednesday.

“We encourage eligible Tulsa County residents to check the email link they have received (if they have registered and are eligible) in order to view those appointment opportunities,” Stephens said.

Dart reiterated the need for more supplies to expand efforts, including getting vaccines shipped to more of the 253 pandemic providers who have signed up to administer vaccinations in Tulsa County.

“We ask everyone to continue to be patient and diligent until supplies are larger,” Dart said in a statement, adding the state “has been very good at getting us our weekly vaccine allotment on time to match our appointments we have in the portal.”

According to Reed, there should be an increased need for booster-dose appointments starting next week, which marks the four-week “anniversary” of the state’s initial push to get elderly Oklahomans vaccinated.

By the numbers

350,548: Total shots administered in Oklahoma

50,371: Oklahomans who've gotten both shots

300,177: Oklahomans who've gotten one shot

16%: Net increase in vaccines to be shipped next week to Oklahoma

190,500: Approximate number of Oklahomans 65+ who've gotten at least one shot

Source: Oklahoma Department of Health, as of Jan. 27

Video: When will COVID-19 vaccines be widely available?

What Oklahomans need to know about the COVID-19 vaccine while signing up in Phase 2

What determines how many appointments are available?

The state is reliant on COVID-19 vaccines supplied by the federal government; officials reportedly are notified of shipments one week at a time. The limited supplies make it logistically impossible to schedule vaccinations weeks in advance. Oklahoma officials hope for a policy change that resupplies be based on states' “burn rate,” of how many shipped doses are distributed promptly. 

States and tribal leaders are receiving federal shipments of vaccines based on population, OSDH leaders have said. Oklahomans with a CDIB card would go to a tribal health care center for vaccines. 

Francisco Seco/AP file

I signed up at vaccinate.oklahoma.gov but never got an email confirmation of any kind — what should I do?

Confirmation emails are sent out in batches; users should receive one within 24-48 business hours of registering. “Emails are sent out over a span of time in the order in which registrations occurred,” the state said. “As a result, some emails may be delayed.” If you've waited at least 48 hours without having gotten a response, it could mean a data-entry error was made by the user during registration. 

State and county health officials also have said most of these issues are resolved when the user checks their junk mail folder for messages flagged as spam. 

I’ve been told I can make an appointment, but I went to the portal and there were none available within 100 miles — what do I do now?

First, if the portal has a link that says "No appointments available," click anyway. Possible glitches in the system might result in that message showing up even when appointments might be open outside the user's immediate area.

If you're still coming up empty, bookmark and keep checking the “Click here” link emailed to you, says deputy OSDH commissioner Keith Reed. The link does not expire and is the only method to check for appointment availability. No further emails will be sent.

SARAH PHIPPS, The Oklahoman file

When will new appointments be added to the online portal as the state is updated on the supply of vaccines expected to ship from the federal government?

A new round of scheduling should be available on the portal every Thursday. Starting 5 p.m. Wednesday through Thursday morning, new appointments are uploaded for distribution pods, said Mindy Spohn, OSDH vaccine facilitator. 

On Jan. 27, Tulsa Health Department added 8,811 new first-dose appointments, compared to 5,480 appointments added the previous Wednesday night. About 5,000 of those appointments were gone within about two hours; by about 1 a.m., all the Tulsa County appointments were gone.

Someone I know is unable to go online to access the vaccination portal — how can they make sure to get an appointment?

The state recommends that those unable to access the online portal ask a family member or friend with internet capabilities to assist them with the registration process.

Some churches have stepped up to help people without internet access register on the portal, as well as those who need a foreign-language interpreter. State officials have said a Spanish translation is forthcoming for the online vaccine portal.

Ian Maule, Tulsa World file

How are 211 and LIFE Senior Services trying to help?

Call center staff at 211 can help Oklahomans connect to resources they may need to physically access the vaccine distribution sites, but they cannot schedule appointments. OSDH helped add to 211 staff, who can collect patients' contact info to pass on to local health departments for phone scheduling. 

LIFE Senior Services is helping callers get scheduled by signing them up on the portal and receiving emails for the patient. Pictured: LIFE Senior Services activities director Amberly Villegas and Geneva Boling.

Stephen Pingry, Tulsa World file

Can I show up at a vaccination site without an appointment to wait for someone to miss their scheduled time?

No, Tulsa Health Department and other sites say those without appointments are not welcome at known vaccination sites. THD says if someone does miss their appointment, those shots may be offered to first-responders in the area who have not been able to get vaccinated yet. 

Tulsa World file

What happens if I am unable to make my scheduled appointment? Can it be changed?

Asking that residents strive to keep their bookings as time slots are in high demand, the state has said that those who miss their scheduled time will need to make a new appointment. Cancellations or scheduling changes can be made through the portal. “There’s been some difficulty with that,” Spohn said. “Sometimes you have to wait 24 hours to be able to get back in and redirect your appointment because it locks up. … That’s among fixes we’re working on on our end.”

Mike Simons, Tulsa World file

At what point do I schedule my second dose or "booster shot"?

The answer seems to change depending on which site a patient received their first dose.

Second-dose appointments may be scheduled at the time of the first shot. It is not required to schedule booster doses through the portal. “Follow the instructions given when you got your first shot,” OSDH Deputy Commissioner Keith Reed said.

Second-dose appointments may also be made via the state portal, and users will be asked whether they need the Pfizer or Moderna shot. Some clinics have had scheduling issues for second doses, Spohn said, so officials are working to ensure those sites aren’t filling up with only first-dose appointments.

Tulsa Health Department says: “You are able to walk in for your second dose without an appt, provided you come at the same time as your first dose. Must bring your vaccination card with you.” Director Bruce Dart said those who got a Pfizer vaccine through Tulsa Health Department should try to come back to the same site 21 days after the prime dose; those who got Moderna should walk back into the same site 28 days after.

In Wagoner County, second-dose appointments cannot be made until one week before the patient is due for the booster shot.

Associated Press file

I can't get an appointment for my booster dose when I am supposed to — is it OK to take it any later?

Those concerned about getting appointments exactly 21 or 28 days after their first dose don’t need to worry; if you’re a little late, it doesn’t cause you to have to restart the shots. You may just take a few more days to reach 95% immunity.

The state says it may take longer for second-dose appointments to show up in the system as those cannot be entered into the system weeks in advance. Because the timing of booster doses means a three- or four-week delay, those scheduling their booster dose via the online portal are told not expect to set the schedule right after the prime dose.

Mike Simons, Tulsa World

Can I choose whether I receive a Moderna or Pfizer shot?

Some clinics have both Pfizer and Moderna available, but basically it’s whatever is available at the time of the appointment at the site.

Mike Simons, Tulsa World

Will I be able to drive-through to get my vaccination or will I have to go inside a facility?

Mindy Spohn said the state is trying at each location to help patients with accessibility issues to be able to drive-through. “The problem with drive-throughs … it does limit our throughput because you have a 15-minute observation period.” She said some sites may have found ways to offer drive-through with observation, "but their ability to reach large numbers is limited because of that."

Mike Simons, Tulsa World

My email says I'm registered but not eligible yet. How and when will I get to make an appointment?

Oklahoma will attempt to exhaust doses within each priority group (thus far: health care workers and those 65 or older) before making vaccines available in further phases of the rollout. Phase 2 also includes those younger than 65 who have comorbidities, but appointments have not been opened up to that group yet, Reed said. He noted older Oklahomans are already having issues signing up and the state doesn't want "an even bigger group competing with them to get appointments."

However, new groups may be added while previous priority groups are still scheduling their appointments. When supplies ramp up from the federal government, state officials have said some of those doses will be made available to pandemic providers including retail pharmacies, primary care doctors and urgent care clinics. Spohn said likely those in Phase 3 and 4 would make appointments directly through those providers rather than through the state portal.

Mike Simons Tulsa World

If I have already had COVID-19, do I still need to consider getting the vaccine?

The short answer is yes. Dr. Jennifer Clark, who leads Project ECHO’s COVID-19 data sessions, said the human body’s natural immunity isn’t fully reliable and can be erratic. She said the response a person’s body will have from the vaccine will be more reliable and robust relative to the body’s natural immune response. Monks recommends waiting 90 days after recovering, especially if those who received monoclonal antibodies or convalescent plasma.

Ian Maule, Tulsa World file

Do I still need to practice the three W’s after getting my vaccination?

Yes, it is vital for Oklahomans to continue to wear masks, wash their hands and watch their distance even after being vaccinated. The vaccine effectively protects recipients, but recipients may still be able to spread the virus to others. The CDC has not yet determined if or when it will stop recommending that people wear masks and avoid close contact with others to help prevent community spread. 

Ian Maule, Tulsa World

Can you be a carrier of the virus after receiving a vaccination?

"We have to assume the answer is yes, you can. In other infectious diseases, this happens pretty commonly, though in others it does not. It won’t be known for another few months as we’ve gotten lots of people vaccinated and then tested with viral swabs," Oklahoma Medical Research Foundation President Dr. Stephen Prescott said.

Ian Maule, Tulsa World

Why do I have to wait 15 minutes before being able to leave after my vaccination, and what side effects are common?

Any adverse reaction that could endanger the patient's health should be evident within 15 minutes, so those receiving the vaccine must agree to observation during that time. Dr. George Monks, president of the Oklahoma State Medical Association, said possible side effects include mild pain or swelling at the injection site, true of any medicine injected into skin. Other possible side effects include mild fever, chills, tiredness and headache. Monks said side effects are almost always mild and are more common in younger people or when receiving the boost dose. Monks said one can think of the symptoms as a sign that the vaccine is working.

CHRIS LANDSBERGER The Oklahoman

I have an autoimmune disorder; is the vaccine safe for me?

Officials counsel all patients with concerns about their medical history to consult their primary care physician before scheduling a COVID-19 vaccine. Dr. Stephen Prescott of the Oklahoma Medical Research Foundation says a study is coming “pretty soon” with patients who have Lupus or rheumatoid arthritis. “We will start enrolling patients in that trial under strict safety conditions and test response to the vaccine.”

MIKE SIMONS, Tulsa World file

How many vaccine doses have gone to waste in Oklahoma?

State officials say there is no problem with expiring vaccines; doses arriving each week are already scheduled to be distributed the following week. “We don’t have any vaccine that’s sitting on the shelf,” says deputy OSDH commissioner Keith Reed. He noted small-scale issues like needle errors causing sporadic wasted doses, but nothing on a large scale.

Associated Press file

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January 28, 2021 at 07:13AM
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Extra vaccine appointments being added for Tulsa County with release of some booster doses - Tulsa World

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