- Some people in the United States could start receiving booster doses of COVID-19 vaccines as early as this week.
- The first booster doses will likely be of the Pfizer-BioNTech mRNA vaccine, after a key FDA advisory committee reviewed data on Sept. 17 of its benefits.
- The Biden administration had said earlier this year that booster doses could be rolled out as early as Sept. 20.
COVID-19 booster doses could be available soon for some people in the United States at high risk of severe illness and those who work in jobs that make them more likely to contract the coronavirus.
The first booster doses will likely be of the Pfizer-BioNTech mRNA vaccine, after a key FDA advisory committee reviewed data on Sept. 17 of its benefits.
Several additional regulatory steps remain, but these could be cleared as early as this week.
Over the summer, the Biden administration had said booster doses could be rolled out as early as Sept. 20.
A vaccine advisory committee of the Food and Drug Administration (FDA) voted last week to recommend Pfizer-BioNTech boosters for people 65 years old and older, and those 16 and older at high risk of severe COVID-19 or a higher risk of contracting the coronavirus on the job.
The FDA is not required to follow the panel’s advice but often does. The agency is expected to make a decision this week, according to reports.
The approval would be granted as an emergency use authorization (EUA) rather than a full approval.
This would allow the agency to modify the approval as more data on the benefits of boosters comes in.
A vaccine advisory group for the Centers for Disease Control and Prevention (CDC) is
The CDC’s Advisory Committee on Immunization Practices (ACIP) is also expected to clarify which people are eligible for boosters.
People considered at higher risk of severe illness may include those with chronic lung disease, diabetes, heart conditions, kidney disease, or obesity among other conditions.
Certain people with weakened immune systems who received two doses of an mRNA vaccine are already eligible for an additional dose. This is not considered a booster, but a way to help them generate a more robust immune response.
Jobs that would qualify people for boosters because they have a higher risk of coronavirus exposure could include healthcare workers, emergency responders, and teachers.
Booster doses for the other two COVID-19 vaccines approved in the United States will follow the same regulatory review, although the timeline for these is unclear.
Data needed by the FDA for its review of booster doses of the Moderna and Johnson & Johnson vaccines will not be available for several weeks, President Joe Biden’s chief medical adviser, Dr. Anthony Fauci, told NBC’s “Meet the Press” on Sept. 19.
Moderna announced at the beginning of September that it had submitted initial data to the FDA for its booster application.
Johnson & Johnson has also submitted some booster data to the FDA, the company announced this week.
The J&J vaccine received emergency approval in February as a single-dose vaccine. A booster dose would be a second dose of this vaccine. Data released Sept. 21 found that a J&J booster improved vaccine effectiveness to 94 percent, according to the company.
Even as the country prepares to roll out booster doses to some people in the United States, scientists continue to debate the need for these additional doses.
Some experts point to the decline in antibody levels and increase in breakthrough infections during the months after vaccination as signs of waning immunity.
Real-world data from Israel and the United Kingdom has found a similar decrease in vaccine effectiveness against infection.
However, antibodies are only one aspect of protection against the coronavirus.
Some research has found that the body’s cellular immune response — B cells and T cells — remains robust even 6 months after COVID-19 vaccination.
This suggests that the vaccines will continue to protect against severe illness.
“Even though antibody levels wane over time — that part is clear — it does not necessarily mean that you’re going to end up being extremely sick,” said Ralph Pantophlet, PhD, an associate professor at Simon Fraser University, who studies antibody responses to HIV and other viruses.
UK data found that vaccine effectiveness against hospitalization and death remained strong 20 weeks after vaccination.
However, Israel data shows an increase in severe illness among older adults who were vaccinated earlier in the year, compared to those who received their second dose more recently.
Scientists will continue to monitor fully vaccinated people to see if there is a rise in severe COVID-19 or death among certain groups.
Part of the debate over boosters centers on what level of risk countries are willing to accept.
“Some people feel that protection against severe infection and death should be the measure [of vaccine effectiveness],” said Pantophlet. “So if we can protect against those, then we don’t need to worry about boosters right now and increasing antibody levels.”
Israel has come down on the side of protecting against not only severe illness but also against coronavirus infection. The country has offered boosters to people as young as 12 years old.
The United States has opted to target only those most at risk of severe illness or work-related infection.
The authors of a recent
They write that boosting could be appropriate for some individuals, such as the immunocompromised or those who received a vaccine with low efficacy.
But they point to the need for more and better data on boosters.
“Widespread boosting should be undertaken only if there is clear evidence that it is appropriate,” they wrote.
Boosting may also not have as much of an effect on the population as making sure that everyone has access to initial doses of the COVID-19 vaccines.
“Current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” the authors of the Lancet article wrote.