Administration

People Injured by the COVID-19 Vaccine Need More Help from the Federal Government

by Matt Gontarchick

No vaccine is perfect, and unfortunately, COVID-19 vaccines have caused serious adverse side effects in a tiny percentage of people.   For those whose side effects are severe enough to put them out of work or generate high medical bills, the federal government can provide benefits via the Countermeasures Injury Compensation Program (CICP).  This program is not to be confused with the National Vaccine Injury Compensation Program (VICP), which does not address caused by COVID-19 vaccines.  Examples of serious side effects from COVID-19 vaccines can include blood clots, long-lasting shoulder pain, and swelling of the tongue. 

However, the CICP is not up to snuff, and the majority of claims are not being addressed.  As public health officials continue to encourage Americans to get vaccinated against COVID-19, how can the government better serve those who face rare yet serious consequences from doing the right thing and getting their shots?

The CIPC, explained.  Created in 2010, the CICP was created to provide compensation for injuries resulting from any vaccination, medication, or other device that’s recommended to treat against a declared pandemic, epidemic, or security threat such as Ebola, Zika, and anthrax. 

In March 2020, then-HHS Secretary Alex Azar issued a declaration to provide liability immunity for countermeasures like vaccines and treatments related to COVID-19.  He also directed the CICP to provide benefits to individuals who “sustain a serious physical injury or die” from a COVID-19 countermeasure. 

In terms of coverage, the CICP provides $50,000 a year to replace lost wages and reimburse out-of-pocket medical expenses.  If a person dies, a next-of-kin can receive up to $370,376.  Those who are injured by a countermeasure can request compensation by filing a request and submitting medical records within one year from the date the countermeasure was administered.  CICP medical staff then process to review compensation claims, and those who feel their claims are unfairly rejected can review an appeal before an independent panel.   

Unfortunately, many claims are not being address.  As of October 2021, over 1,300 countermeasure claims linked to COVID-19 vaccines remain pending before the CICP independent panel.  Since its creation over a decade ago, the CICP has only compensated 29 claims – none of which stem from the COVID-19 pandemic.

One of these unaddressed claims belongs to Cody Flint, an agricultural pilot from Mississippi who has been experiencing serious health issues after getting vaccinated for COVID-19 in February 2021.  Sen. Cindy Hyde-Smith (R-MS) shared Flint’s story to Health and Human Services (HHS) Secretary Xavier Becerra in a May 4th congressional hearing, where she remarked that CICP has shown a lack of urgency and transparency in addressing claims. 

In response, Becerra didn’t provide any information on how CICP is addressing the backlog of claims.   Instead, he voiced agreement on the importance of providing transparency, and he explained he wants to make sure no one is “gaming the system” so that “those who really have medical issues to report are the ones who are receiving assistance.” 

However, Becerra did seemingly acknowledge that many claims aren’t being addressed, saying “we’ve heard this story before,” and he promised to put a member of his staff in touch with the senator to provide further details. 

Some lawmakers aren’t waiting around for the administration to take action on CICP claims, though.  Hyde-Smith is a cosponsor of the Countermeasure Injury Compensation Fund Amendment Act, which would update CICP’s adjudication framework and create a new commission to look at countermeasures specifically caused by COVID-19 vaccines.  Unfortunately, the backlog of CICP claims hasn’t captured the attention of many lawmakers so far.  The Senate bill has only garnered thee cosponsors as of this writing, and only one House bill has been introduced that would address CICP in some fashion.  Thus, it doesn’t seem like either measure has a shot at advancing in Congress anytime soon. 

While the number of countermeasures arising from COVID-19 vaccines remains incredibly small, people who’ve legitimately suffered from countermeasures deserve compensation.  Although the federal government seems aware of the fact that the CICP claims backlog is nothing short of outstanding, without any additional commentary from top HHS officials like Becerra, it remains unclear if and when the administration will take action to address the backlog.   In the meantime, the best course of action for people impacted by countermeasures is to continue to advocate for changes at CICP, with the hope that more lawmakers will take notice and put pressure on the administration to get the program in order.

FDA

Is Public Pressure Impacting the FDA’s Vaccine Review Strategy?

by Matt Gontarchick

Parents of young children are frustrated and mad.  While adults have been able to get third and even fourth COVID-19 vaccines doses for some time now, children under six years are still unable to get their shots while the rest of society reverts to a pre-pandemic normal.

Anger among parents hit a boiling point last week when White House Chief Medical Advisor Dr. Anthony Fauci confirmed reports that the Food and Drug Administration (FDA) will not approve vaccines for kids under 6 until it can simultaneously review and approve vaccines from both Pfizer and Moderna.

However, less than a week later, FDA officials seemingly changed course when they announced that they may move forward on reviewing Moderna’s vaccine without waiting for Pfizer’s application – meaning that young children could get vaccinated as soon as June.  What caused the FDA to take an about face on its vaccine review strategy?

At the time of Fauci’s comment on April 21, Moderna was poised to begin applying for an emergency use authorization (EUA) within the next week or two, as initial data showed its vaccine generated strong protection in kids.  News that the FDA could soon begin reviewing Moderna’s EUA application set off a sign of relief among parents, who have had to contend with constant delays in the race to get young kids vaccinated.

However, Pfizer’s vaccine for children under 5 is still undergoing clinical trials for a three-dose regimen after results from a two-dose regimen did not yet provide strong protection against the virus, and it’s not clear when Pfizer will be ready to submit its data.  By waiting to review vaccines from both companies, the timeline for getting shots into kids’ arms faced a decent chance of getting extended once again.

What was the FDA thinking?  According to reports,  FDA officials wanted to review vaccines from Moderna and Pfizer simultaneously because approving both at the same time would be less confusing for parents than approving each at different times.  Additionally, FDA officials were worried about a possible backlash from parents if the agency approved Moderna’s vaccine first and Pfizer’s several week later when Pfizer’s vaccine demonstrated stronger efficacy. 

Despite the FDA’s rationale, reports that federal officials were delaying the review process once again elicited a strong backlash from concerned parents and lawmakers.  In the days following Fauci’s comments, lawmakers wrote to the FDA requesting an explanation as to why vaccines for young children were being delayed again, and parents and pediatricians launched an advocacy campaign to urge the FDA to review each vaccine application “at the earliest opportunity.”

Did Public Pressure Make a Difference?

The FDA finally changed its tune on April 29, when a top official announced the agency will consider vaccine applications as soon as they are ready.  While it is not clear if the FDA shifted its strategy purely in response to political and public pressures, it wouldn’t be first time public pressure might have made a difference. 

In mid-2021, the FDA appeared to be on track to approve the vaccine for children aged 5-11 by early fall, just in time for the start of school.  However, in July, the FDA asked Pfizer and Moderna to expand the size of their clinical trials for children to make sure they could detect potentially rare side effects, namely myocarditis, or heart inflammation – effectively pushing the timeline for vaccine approval out to winter 2021 or early 2022.  This drew sharp criticism from parents and pediatricians, who argued that complications from COVID-19 posed a greater threat to kids than myocarditis.

The strongest sign of pressure on the FDA came in the form of an August 2021 letter from the American Academy of Pediatrics (AAP) that called on agency to stick to its original timeline for collecting data and authorize vaccines for children under 12 as soon as possible.  A month after the pediatricians weighed in, the FDA issued an unprecedented statement saying that it would no longer wait for additional follow-up data from expanded clinical trials to made a decision on an EUA and stick to its original timeline. 

Like many things with the pandemic, nothing is certain as the FDA determines how it will review vaccines for younger children.  Moderna only began to submit data for its EUA on April 28, and the FDA has laid out a tentative schedule that leaves open the possibility that kids under 6 could get their shots sometimes this June.  However, things could still change. An FDA official say the agency could still review EUA applications from Moderna and Pfizer simultaneously if both are filed less than a week apart, and many parents and pediatricians say June is still too long of a wait for young kids to get vaccinated, especially considering that the review process for other age groups took less time. 

However, actions undertaken by the FDA last fall and last week suggest that the agency isn’t immune to public pressure.  This sets up a precedent where advocacy could sway the FDA review process in the future – for better or for worse.

FDA

When Can Kids Under 5 Get Vaccinated?

by Matt Gontarchick

An average 672 children per day last week were admitted to the hospital with COVID-19 last week, the highest number since the COVID-19 public health emergency began.  Surging case numbers are also causing schools to close and temporarily revert to virtual learning.  While children ages 5-17 can be vaccinated for protection against COVID-19, this currently isn’t an option for children under 5 years of age.  Even though pharmaceutical companies have been working on vaccines for younger children, some bumps in the road means the timeline for getting this cohort vaccinated hasn’t exactly been static.

Pfizer’s Swing and a Miss

Pfizer was the first COVID-19 vaccine developer to begin testing vaccine in children under five.  For its late-stage clinical trial, Pfizer administered two 3-microgram doses three weeks apart, which is less than one-third of the dose given to older children. 

Pfizer initially hoped to submit data on the efficacy of its vaccine in children in the first quarter of 2022, but an announcement from the company on December 17, 2021 signaled a delay in the timeline young children can get vaccinated.  According to Pfizer, its 3-microgram dose yielded high level of protection in children ages 6- to 24-months-old but did not generate a sufficient level of protection in children ages 2 to 5. 

Now, Pfizer is amending its clinical trial to add a third 3-microgram dose for children 6 months to 5 years of age.  If the updated trials are successful, Pfizer says it will submit data to the Food and Drug Administration (FDA) in April, which pushes the timeline for young children to get the company’s vaccine back by a few months. 

What about Moderna?

News that Pfizer is extending its trial left parents of younger kids understandably upset.  Fortunately, Pfizer is not the only company developing vaccines for children.  Moderna is currently conducting trials in children ages 6-months to 5-years-old, and the company expects to have results available by the end of January, which means the FDA could provide emergency approval as soon as late February or early March 2022.  Moderna is also testing younger children with a higher-microgram dosage than Pfizer, which presumably increases the likelihood that Moderna’s vaccine will yield an adequate immune response.

Children’s Risk Still Very Low

Even though it will probably be a few more months until younger children can get their shot, parents should feel some assurance that young children’s risk of complications from COVID-19 is extremely low.  The COVID-19 death rate for children ages 0-17 in the US is 0.1%, by far the lowest for any age group (in comparison, the death rate for US adults ages 50-64 is 1.39%). 

While pediatric hospitalizations related to COVID-19 are at a record-high, many of these hospitalizations are incidental, meaning children are being hospitalized with, but not for COVID.  An example of an incidental pediatric hospitalization could be for a child who falls on the playground, is admitted to the hospital for a broken bone, and only tests positive as a part of routine screening.

Additionally, young children who are infected with COVID-19 overwhelmingly exhibit mild symptoms or are asymptomatic, with hospital stays rare.  And while it is possible that young children can become COVID-19 long-haulers, studies are increasingly showing that long-COVID in kids is also rare. 

News of Pfizer’s clinical trial results was certainly disappointing for parents.  But with the possibility of better clinical trial results in the future plus strong data on the low level of risk for young children, parents should have a somewhat optimistic outlook heading into the third year of the pandemic.

Administration

Will the Definition of “Fully Vaccinated” Change?

by Matt Gontarchick

Right now, “fully vaccinated” means two shots of an mRNA vaccine or one shot of the Johnson & Johnson vaccine.  But that could change.  In a recent interview, NIAID Director Dr. Anthony Fauci said the definition of fully vaccinated could change from two to three mRNA doses as mounting evidence shows waning efficacy of a two-dose regimen over time.  With the administration now recommending all US adults to get their COVID-19 booster shots, is it just a matter of time until the definition of fully vaccinated changes from two to three doses?

The Evidence for One More Shot

Evidence shows that the immunity against infection from COVD-19 does wane over time, including cases that are asymptomatic or mildly symptomatic.  A study from the Centers for Disease Control and Prevention (CDC) published in September found effectiveness against infection among adults in New York fell from 92% to 75% between May and July 2021.  Additionally, a study based on data from the Veterans Health Administration (VHA) found effectiveness against infection among veterans fell from 88% to 48% between February and October 2021.

However, evidence suggests that vaccine effectiveness against severe disease and hospitalization remains strong, despite declining protection against infection  The New York study found vaccine effectiveness in preventing hospitalization only declined from 95% to 90% over the three-month period, while a study in the Netherlands found vaccine effectiveness against hospitalization remained unchanged at 94% between July and October 2021. 

New Variant, New Urgency

Concerns that the new Omicron variant is both more transmissible and may be somewhat resistant to immunity from vaccines or prior infection is underscoring an emphasis from the Biden administration on booster shots.  On November 29, the CDC updated its COVID-19 booster recommendations to say everyone ages 18 and older “should” get a booster shot as added protection against the new variant.  A few days later, President Joe Biden announced a new plan to ensure that the nearly 100 million eligible Americans who have not yet received their booster shots do so as soon as possible.  The plan includes:

  • Sending texts, calls, and emails to eligible Americans.
  • Launching a new public education campaign.
  • Expanding pharmacy availability through December 2021.

While it’s too early to tell how much protection current vaccines will offer against the Omicron variant, experts say the higher antibody response generated by a booster shot could provide broad protection against new variants.  Experts are also keen to stress that Delta remains the dominant variant in the US, and it remains unknown if Omicron will eventually become the new dominant strain.  With the Delta variant already contributing to a rise in cases nationwide, booster shots remain as important as ever. 

If booster shots are so important regardless of which variant is circulating, then why doesn’t the administration just change the definition of fully vaccinated from two shots to three?  First of all, some public health experts fear changing the definition suddenly could spark confusion.  The FDA and CDC only authorized booster shots for all American adults just before Thanksgiving, and new changes could be problematic given the current administration’s challenges in communicating public health information and guidelines. 

More importantly, changing the definition of fully vaccinated to three shots could undermine efforts to reach Americans who have yet to receive their first two shots.  Only about 60% of American adults have been fully vaccinated, and some public health experts believe efforts to reach the unvaccinated would be more effective in preventing a spike in hospitalizations than convincing young, health Americans to get a third dose.  Still as evidence on waning immunity mounts and concerns over the Omicron variant rise, it remains a possibility that the federal government could revise its definition of fully vaccinated some time next year. 

Administration

What’s Going on with Booster Shots?

by Matt Gontarchick

There’s been a lot of discussion about COVID-19 booster shots lately – so much so, that it’s hard to keep track of who can get booster shots and what kind of booster shots are available.  Here, we provide a lay of the land on booster shots.

Why are booster shots necessary?  Booster shots provide an extra “boost” to immunity through an additional dose that cues the immune system to produce a stronger antibody response.  While all three currently approved vaccines from Pfizer, Moderna, and Johnson & Johnson are highly effective in protecting against hospitalization and death, a growing number of studies show that vaccine efficacy gradually wanes over time. 

Who can get booster shots now?  Pfizer’s COVID-19 vaccine is the only vaccine that is currently authorized by the Food and Drug Administration (FDA) to be used as a booster dose.  The FDA formally amended the emergency authorization use (EUA) for the Pfizer vaccine on September 22.  According to the amended EUA, the following people are eligible for booster shots at least six months after their initial series of shots:

  • People over age 65.
  • People ages 18 to 64 at high risk of severe COVID-19 due to chronic medical conditions or compromised immune systems.
  • People with greater risk of workplace exposure, such as frontline medical workers, teachers, and emergency responders.

More booster shots are on the way.  The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted during an October 14-15 public meeting to recommend booster doses from Moderna and Johnson & Johnson. The panel recommended the Moderna booster be administered under the same criteria as Pfizer’s – six months after the second dose for people over 65, individuals at risk for serious complication from COVID-19, and essential workers.  However, the panel recommended broader criteria for the Johnson & Johnson booster – it said anyone who received the single dose Johnson & Johnson vaccine should be eligible to receive a second booster dose at least two months later. 

  • Why? Several studies have shown the Johnson & Johnson vaccine is less effective that other currently approved shots, particularly against new variants like Delta.

What happens next: The CDC Advisory Committee on Immunization Practices (ACIP) will meet on October 20-21 to offer its recommendations on who should get the Moderna and Johnson & Johnson booster shots.  Its recommendations are subject to a final decision from the CDC director.  Afterwards, the FDA could officially authorize booster shots from both companies in the following days. 

The conversation on booster shots hasn’t been without controversy.  Over the past few months, scientists, researchers, and public health officials within the federal government haven’t seen eye-to-eye on when booster shots should become available, and who should get them. 

  • For example, CDC Director Rochelle Walensky partially overruled ACIP last month when the panel initially declined to offer booster shots for essential workers under 65 who do not have chronic medical conditions.  Some ACIP members said that without additional data, they weren’t comfortable automatically allowing younger people to get boosters just because of their jobs.  While Walensky acknowledged the panel’s uncertainty, she said in a statement that CDC must use “imperfect data” to “take actions that we anticipate will do the greatest good.”
  • There are also ethical considerations as billions worldwide remain unvaccinated.  While many public health experts believe people with chronic health conditions should get additional shots, they feel extra doses should be allocated to countries with low vaccination rates first in order to prevent more dangerous variants from developing. 

The administration’s internal disputes have been quite apparent to the public.  Back in August, President Biden announced a plan to start distributing booster shots to all eligible Americans as soon as September 20.  However, the health care agencies tasked with rolling out boosters have taken a more conservative approach, and one month later after Biden’s original deadline, only certain segments of the population have access to one vaccine booster.   

With limited information and uncertainty about the future of the virus, administration officials are between a rock and a hard place.  On one hand, federal officials don’t have enough data to make definitive decisions on who needs a booster and how much a booster would improve efficacy.  On the other hand, the administration knows it can’t wait for definitive findings to become available, especially if case number surge once again in the next few months as colder temperatures drive more Americans indoors.

At the end of the day, COVID-19 is still a novel virus, and there are many unanswered questions on how long protection from vaccines last and how much that protection varies between different groups of people.  While new data on vaccines will continue to gradually become available, federal health officials will have to continue discussing and weighing the risks and benefits of authorizing vaccines in the US.   

Administration

What Employers Need to Know About the New Vaccine Mandate

by Matt Gontarchick

The White House says it’s time for the unvaccinated to roll up their sleeves.  To help boost vaccination rates as the Delta variant continues to take its destructive toll across the nation, President Biden laid out a new COVID-19 action plan with some new requirements for private businesses.

How it works: The Biden administration is directing the Occupational Safety and Health Administration (OSHA) to develop a rule that will require all private sector employers with 100 or more employees to ensure their workforce is fully vaccinated and require any unvaccinated workers who remain unvaccinated to show a negative test result at least once a week.  Furthermore, the administration says it will require private employers to provide paid time off for employees to go get vaccinated.  OSHA will issue the rule through an emergency temporary standard (ETS) that will take effect immediately upon publication in the Federal Register.

This requirement is expected to impact 80 million workers in the private sector.  

Can OSHA do this?  OSHA has the authority to issue an ETS if it’s been determined that:

  1.  “Employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards,” and
  2. The ETS is “necessary to protect employees from such danger.” 

Remember: OSHA mandated that certain health care workers be vaccinated via an ETS issued in June 2021.

And yes, the mandate is constitutional.  In 1905, the Supreme Court ruled 7-2 to uphold a $5 fine for failing to be vaccinated against smallpox in Jacobson v. Massachusetts.  According to the high court, an individual cannot deprive his or her neighbors of their own liberty by allowing the spread of disease.

What happens next? White House Coronavirus Response Coordinator Jeffrey Zients said on September 10 that the ETS will be drafted “over the coming weeks.”  This means OSHA will release the rule much sooner than the ETS for health care workers, which was in development for six months before being published in June of this year. 

What employers should do.  While OSHA spends the next few weeks developing an ETS, private businesses can do several things to be prepared.

  • Plan for potential costs, including the cost of testing and time off to be tested.
  • Prepare processes to collect vaccination information.  Put in place a system to request, collect, and maintain vaccination information, and designate a group of employees to verify evidence of vaccination status.
  • Create a testing policy.  Figure out whether your organization will offer on-site testing to workers, allow workers to self-administer tests at home, or get tested by a third party.
  • Consider a mandatory vaccine policy that goes further than the ETS and allows your business to forgo the weekly testing option. 
  • Prepare for accommodation requests for employees who do not want to be vaccinated for health or religious reasons.

Prepare for enforcement.  OSHA inspections can be conducted without notice, and the agency has a robust system in place to handle whistleblower-style complaints from employees.

Get ready for lawsuits. The debate over vaccine mandates won’t end after the ETS is issued.  Arizona became the first state to file a lawsuit against the administration on September 16, and 24 Republican state attorneys general threatened to take legal action in a September 16 letter.  Still, employers should continue preparing for the new ETS as OSHA continues to move forward full steam ahead.

FDA

When Are Kids Going to Get Vaccinated?

by Matt Gontarchick

Parents are mad.  While grown-ups have been eligible for COVID-19 vaccines for almost a year, there currently aren’t any options for children under 12.  This is especially concerning for many parents as the kids return to school amid a nationwide surge in cases.

A Different Process

On September 20, Pfizer/BioNTech released data showing its mRNA vaccine is safe and effective in children aged 5-11.  As the Food and Drug Administration (FDA) has fully approved the vaccine for individuals aged 16 and older and Pfizer/BioNTech vaccine is still available to individuals aged 12 to 15 through emergency authorization, why is the approval process taking so long for children?   

  • More data.  Earlier this year, FDA asked Pfizer/BioNTech and the other vaccine developers to provide six months of follow-up data for all clinical trial participants.  In comparison, the approval process for adults only required two months of follow-up data. 
  • More scrutiny.  Unlike the emergency use authorization (EUA) for adults, FDA doesn’t just rely on a company’s summary of the clinical trial data for children’s vaccines.  The agency looks at individual reports from every child, including data on side effects and blood tests. 
  • Biological differences.  Kids aren’t simply smaller adults.  Children have more active immune systems than grown-ups, which means scientists need to ensure they’re providing the right dosage.  Pfizer/BioNTech has specifically been testing children aged 5-11 with a two-dose regimen administered three weeks apart.  Each dose contains 10 micrograms, which is about a third of the dosage used for individuals aged 12 and up.

Pressure Grows for FDA to Speed Up Timeline

Earlier this year, it appeared that FDA would be able to approve vaccines for children aged 5-11 by early fall, just in time for the start of school.  However, signs that the approval timeline would extend first appeared in July when FDA asked Pfizer and Moderna to expand the size of their clinical trials for children to make sure they could detect potentially rare side effects, namely myocarditis, or heart inflammation.  These changes caused many health experts to revise their predictions on a timeline for approval for EUA, with some saying that the FDA would not make a decision until winter 2021 or early 2022.

The prospects of a longer timeline combined with a nationwide surge in cases sparked panic among many parents of younger children.  While COVID-19 poses a low risk for healthy kids, there is a justifiable concern about immunocompromised children as well as the ability for kids to pass the virus onto vulnerable adults.  As a result, some parents are even looking for doctors to skirt the rules and vaccinate their children, while others are signing their kids up for clinical trials, even though it’s unknown whether their child will be receiving the vaccine or a placebo.

Pressure from Pediatricians: The American Academy of Pediatrics (AAP) urged the FDA in an August 5  letter to “continue working aggressively towards authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible” due to the threat posed by the Delta variant.  Specifically, AAP indicated that a two-month follow-up period to collect safety data is sufficient, as opposed to the six-month period FDA initially requested.  AAP also noted that reported cases of myocarditis in children who are receive mRNA vaccines like Pfizer/BioNtech’s are “extremely rare.”

The FDA is listening and took the rare step of publicly responding to the concerns around approving a COVID-19 vaccine for children on September 10. .  In addition to vowing to adhere to strict safety standards, FDA stated clinical trials are required to have a “follow-up period for safety data of at least about two months,” indicating a change from the previously requested six-month follow-up period.

The Timeline, Revised

With the FDA apparently open to a shorter follow-up period for safety data, what does the approval timeline look like now?  At the the Morgan Stanley Global Healthcare Conference 2021 on September 14, Pfizer CEO Albert Bourla laid out a new estimated approval timeline for children aged 5-11. 

  • Pfizer to have all safety and immunogenicity date in late September (topline results were released on September 20).
  • Pfizer to file for EUA in early October.
  • FDA to approve EUA within 3-6 weeks, meaning children aged 5-11 could get their shots as soon as late October or early November. 

Bourla also said Pfizer will likely have enough data on how well its vaccine works on children under 5 years of age as early as the end of October, putting that vaccine on the path for EUA by the FDA by the end of the year. 

This is reassuring news for parents of kids aged 5-11, to potentially have a vaccine available by Halloween than, say, early 2022.  But let’s not get our hopes up as COVID-19 has proven itself to be an incredibly unpredictable virus, and changing conditions could cause scientists and regulators to shift their approval considerations once again.

FDA

Everything You Need to Know about COVID-19 Booster Shots

by Matt Gontarchick

Every year, you get your flu shot.  Will the same be said for COVID-19 shots?  No one knows for sure, but federal officials and public health experts are weighing in on whether certain people might need COVID-19 booster shots as soon as this fall.  With questions about the longevity of vaccine-induced immunity and the potential for vaccine-eluding variants still unanswered, it certainly does not hurt to prepare.

What Is the Administration Planning?

On May 11, David Kessler, MD, Chief Science Officer of the White House COVID-19 Response Team, told a Senate panel that the Biden Administration is preparing for the possibility of booster shots for people who do not have a robust or long-lasting immunity, or if new variants evade protection from previously-administered vaccines.  Kessler said the booster shots would likely be a third shot of Pfizer or Modern’s mRNA vaccine rather than a new shot tailored to emerging variants.  He also confirmed that the booster shots would be free to Americans and funded by congressional appropriations through the end of Fiscal Year (FY) 2021.  Since Kessler’s testimony, the Administration purchased 200 million additional doses of Moderna’s COVID-19 vaccine in June to vaccinate children or to serve as a booster shot for adults.  Any decision to use booster shots would be up to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

Kessler’s testimony was not the first time someone raised the possibility that people vaccinated against COVID-19 could need booster shots in the future.  In February, Johnson & Johnson CEO Alex Gorsky said COVID-19 booster shots may be needed annually, like flu shots.  Similarly, Pfizer CEO Albert Bourla said in April that people will likely need a third dose of a COVID-19 vaccine within 12 months of being fully vaccinated. 

How Long Does Immunity from Vaccines Last?

Since the vaccines were just developed in 2020, experts say only time will tell how long protection from the vaccines will last.  Of the few studies conducted so far, research from the New England Journal of Medicine published in April 2021 found Moderna’s COVID-19 vaccine can produce strong antibody protection for at least six months following the second dose.  Pfizer also announced research findings in April confirming its vaccine’s efficacy six months after the second dose.  

However, new research suggests it could be for a year or longer.  A pair of studies published in May 2021 found that the B-cells of people infected with COVID-19 still continued to mature and strengthen one year after infection, suggesting some type of immune response.  More recently, a study published in the journal Nature in June suggested immunity from mRNA vaccines could last for years.

What about the Variants?

However, many of these studies were conducted before the Delta variant became more prevalent.  Public health experts say the Delta variant, which was first discovered in India in October 2020, is 43-90% more transmissible than previous COVID-19 variants, leading some to believe that currently-approved vaccine are less efficacious against the  Delta variant.  A recent study said the Delta variant could become dominant in the US by mid-July.

Fortunately, the vaccines still offer strong protection.  According to a study by Oxford University researchers, two doses of the Pfizer vaccine appears to provide 79% protection against the Delta variant, compared to 92% against the Alpha variant, which is currently the dominant variant in the US, and was first discovered in the United Kingdom in September 2020.  Since the Moderna vaccine uses the same mRNA technology as Pfizer’s, it can be inferred that two Moderna doses offer the same levels of protection as the Pfizer vaccine provides against the Delta variant. 

But what about the Johnson & Johnson vaccine?  Compared to its Moderna and Pfizer counterparts, the single-dose vaccine has been administered far less, meaning public health officials have little data regarding its effectiveness against the Delta variant.  However, experts say a Johnson & Johnson vaccine is better than no vaccine at all, and that one dose is likely effective at protecting a recipient against serious illness or death.  Additionally, former Senior Advisor to the COVID-19 Response Coordinator Andy Slavitt has said that recipients of the Johnson & Johnson could take a single mRNA booster shot now for added protection.

Nonetheless, just because the current vaccines remain effective against the Delta variant does not  mean they are  necessarily guaranteed to be effective against future variants.  As explained by CDC Director Rochelle Walensky on June 22, the Delta variant represents a “set of mutations” of COVID-19, and future mutations could produce a variant that evades protection from vaccines.  However, scientists say it’s unlikely a variant will arise that will make COVID-19 vaccines totally unless.  While vaccines appear to offer diminishing protection from being infected from newer COVID-19 variants, they still appear effective at preventing hospitalization and death.    

The Jury Is Still Out

The point of vaccines is to protect people from serious illness and death, and until fully vaccinated individuals are finding themselves with infections severe enough to require hospitalization, is it difficult to predict when booster shots will be needed and how often.  In an interview on May 21, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said the need for booster shots is still unclear.  The CDC Advisory Committee on Immunization Practices reached a similar conclusion on June 24, saying there currently is not enough data to determine booster shots are needed, although the panel did not rule out the possibility of requiring booster shots if immunity wanes or new variants render existing vaccines less effective.  Considering this risk, the evolving nature of the virus, and the pain the world has already experienced at the hand of COVID-19, the US government has every reason to prepare for the worst and continue this conversation around COVID-19 booster shots.