Topline
The U.S.'s planned rollout for Covid-19 booster shot for the general population is still in doubt pending approval by governmental regulators. However, White House officials stated Sunday that at most Pfizer shots would likely be available on time and that the administration is ready for a rapid rollout if the shots are approved.
A nurse signs a card containing a third dose of the Pfizer Covid-19... [+] vaccine for coronavirus. It was dated August 19, in Pasadena (California). AFP via Getty Images
The Key Facts
Mid-August, the Biden administration stated that Pfizer/BioNTech and Moderna recipients would receive booster shots starting on September 20. However, the New York Times reported that this timeline could be in doubt. The shots have yet to be approved by the Food and Drug Administration and the vaccine advisory panel of the Centers for Disease Control and Prevention. CBS Face the Nation's Dr. Anthony Fauci admitted that it is possible that only Pfizers shots will be approved by the 20th. Modernas shots will likely be delayed for a few weeks while the FDA gathers more information from the company. He said that the FDA and CDC will determine who is eligible for the booster shot. There are currently studies to determine if booster doses can be mixed and matched. For instance, if the first two doses of Moderna were administered by the FDA, Fauci stated that the government recommends that booster shots of the same vaccine be given. Ronald Klain, White House Chief Of Staff, stated on CNN that the Biden administration will make booster shots available to the public as soon as they are approved. The administration also has sufficient supply and a distribution plan in place to ensure the availability of the third shot when it is ready. Fauci stated last week that health officials will continue to recommend booster shots for people eight months after the second dose. President Joe Biden suggested that it might be after six, but it all depends on the FDA and CDC's final decision.
Important Quote
We are still hopeful that at least one vaccine will be available by September 20. The Biden administration is also ready to go once booster approvals are granted, Klain stated on CNN. Klain added that the FDA and CDC will ultimately decide which vaccines will be approved for boosters. They will determine who will receive it.
What we don't know
The Johnson & Johnson vaccine booster shot, which is an adenovirus-based shot and uses a different technology from Modernas mRNA vaccinations, will be approved. Federal health officials believe that the one-dose vaccine will require a booster shot. However, they are waiting for more data to make an official recommendation. This includes whether the vaccine could be mixed in with booster shots of the Moderna or Pfizer vaccines. Johnson & Johnson data released in August showed that a second shot of vaccine results in a strong increase in antibodies against the coronavirus. This could indicate the approval of booster shots.
Surprising Fact
Even though booster shots are not yet approved for general public use, some people still choose to get them despite the fact that health officials have warned against it. Many Americans have taken it upon themselves to get the third shot due to the delta variant surge. They may even make an appointment for a vaccine and claim to not be vaccinated. ABC News reported on August 11 that an internal CDC document found that an estimated 1.1million people had received an unauthorized booster shot. This number is probably an undercount.
Important Background
Fauci's acknowledgment of Modernas approval delay is consistent with previous reports suggesting Modernas shot might not be ready in the timeframe. Forbes was told earlier this week by a source who is familiar with the approval process that Pfizer will be available for the September 17 FDA meeting regarding booster shots. Modernas vaccine approval has been delayed largely because Moderna submitted data for a lower dose of booster shots. However, the FDA wants data for a 100-microgram dose that is equal to the initial shots. According to the Associated Press, Pfizers approval process is faster because of the substantial data the company has from Israels booster shot program using its vaccine. The U.S. already approved third doses to vaccines for immunocompromised populations, which make up about 3% of the population. Pfizers planned booster rollout follows other countries such as Israel, France and Germany that have begun to administer or plan to administer booster shots. The booster shots were developed in response to concerns that the effectiveness of Covid-19 vaccines may wane over time, as some studies suggest. Although the vaccines are less effective in preventing infection from the delta variant of the disease, they remain extremely protective against death, severe illness and hospitalization.
Chief Critic
The World Health Organization (WHO), has condemned wealthy countries for distributing booster shots before many other countries have inoculated large numbers of people with their initial doses. This is because of concerns about vaccine inequity and questions about booster shots' efficacy. There are also fears that coronavirus variants could emerge from low-vaccination countries.
Continue reading
Moderna will likely miss the Booster Deadline (Forbes).
More than three quarters of vaccinated Americans plan to get Covid-19 booster shot, according to Poll Findings (Forbes).
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