FDA likely to approve Covid vaccine boosters for all Americans after SIX months instead of eight months previously announced by Biden administration
- Federal health officials likely to approve six months after their last dose of COVID-19 vaccine boosters for all Americans instead of eight months
- Sources say timeline has accelerated as data under investigation by federal regulators shows boosters are given after six months
- Boosters for all three vaccines – Pfizer-BioNTech, Moderna and Johnson & Johnson – expected in mid-September
- Currently, only immunocompromised Americans are eligible for a third injection of the vaccine
The U.S. Food and Drug Administration (FDA) will likely approve COVID-19 vaccine booster injections for all Americans six months after receiving their last shot, instead of the one announced by the Biden administration eight months earlier.
A person familiar with plans told The Wall Street Journal the timeline change is because data being examined by federal regulators looks at boosters given after six months.
The source said approval for additional doses for all three vaccines — Pfizer-BioNTech, Moderna and Johnson & Johnson — is expected in mid-September.
Both a White House spokesperson and an FDA spokeswoman declined to comment to the Journal about when approval should be expected or how soon after a final dose of boosters will be recommended.
Federal health officials will likely approve six months after their last dose of COVID-19 vaccine boosters for all Americans instead of eight months. Pictured: Rosa Gallegos, 31, gets vaccinated against COVID-19 in Los Angeles, August 11
The Biden administration initially announced plans for booster shots for the COVID-19 vaccine last week.
At a media briefing, officials said adults over the age of 18 who have received the Pfizer-BioNTech and Moderna vaccines will be able to receive a third dose starting the week of Sept. 20.
At the time, there were no plans for those who received the one-time Johnson & Johnson vaccine.
Currently, booster shots are only approved for immunocompromised Americans ages 12 and older.
To be approved for the entire U.S. population, the decision must be approved by the FDA and a recommendation made by the Centers for Disease Control and Prevention (CDC) advisory committee.
Among the first to receive boosters will likely be health professionals, nursing home residents and other elderly Americans, who were some of the first Americans to be vaccinated after the injections were authorized for emergency use last December.
Officials also plan to recommend that people get a booster made from the same company as their first two shots.
This means that people who receive two doses of the Pfizer vaccine should receive a third dose of Pfizer, and those who received two doses of the Moderna vaccine should receive a Moderna booster.
Two weeks ago, the FDA expanded the emergency use authorization of the Pfizer and Moderna vaccines to allow them to be administered as boosters to people with weakened immune systems, citing their greater risk of contracting the virus and the evidence that the effectiveness of the vaccines declined over time. .
More and more research has shown that people with weakened immune systems have low or undetectable antibody levels, even after two doses.
A study in May found that all cancer patients developed fewer antibodies after vaccination compared to healthy participants and that 10 percent developed hardly any antibodies.
Another study in June looked at 30 organ transplant recipients and found that 24 developed negative antibody levels — meaning they had no immune-fighting cells — after two doses of the Pfizer-BioNTech or Moderna vaccines.
Despite this evidence, the World Health Organization (WHO) called for a moratorium on COVID-19 vaccines until each country could vaccinate at least 15 percent of their population.
However, third doses are currently approved in several countries, including Chile, France, Germany and Israel.
Israel, which has exclusively administered the Pfizer injection, has offered a booster to people over 60 who had been vaccinated more than five months ago in an effort to contain its own rise in cases of the Delta variant.
France and Germany have also approved third doses for vulnerable populations with plans to start giving the injections next month.