FDA Likely to Approve Covid-19 Boosters at Six Months Instead of Eight

WHAT YOU NEED TO KNOW:

• Federal regulators could approve a Covid-19 booster shot for fully vaccinated adults starting at least six months after the last dose, the Wall Street Journal reported.
• The initial plan was to administer the boosters eight months after full vaccination.
• Approval of boosters for Pfizer/ BioNTech, Moderna and Johnson & Johnson is reportedly expected in mid-September.

The US FDA is likely to approve a COVID-19 booster shot for adults beginning at least six months after full vaccination, according to a report from the Wall Street Journal on Wednesday. Initially, the plan was to administer the boosters eight months after the previous two-dose.

Pfizer Inc and partner BioNTech SE, Moderna Inc and Johnson & Johnson, the three COVID-19 vaccines being administered in the USA are all seeking approval for boosters. The FDA is expected to grant approval in mid-September, according to the report said.

The first to start the application process for approval is Pfizer and BioNTech. It says its booster shot for people 16 and older spurs a more than three-fold increase in antibodies against Covid-19.

The US FDA granted full approval to Pfizer’s two-dose vaccine Monday. On Wednesday, Moderna said it has completed the real-time review needed for full approval for its vaccine in people 18 and older.

During her daily briefing, White House spokeswoman Jen Psaki said Wednesday that any such development would be under the purview of the Centers for Disease and Control and Prevention (CDC).

According to the CDC, the Biden administration’s plan to administer booster shots depends on pending approval from the FDA and recommendation to it from the Advisory Committee on Immunization Practices.

The FDA, however, reiterated its joint statement from last week that said the government was gearing up to roll out the third shot from mid-September to Americans who had their initial course of two-dose vaccines made by Moderna and Pfizer more than eight months ago.

The rollout would start if the FDA and the CDC decide that boosters are needed, U.S. officials had said.

In the U.K., a study of more than 400,000 people who had been fully vaccinated of the Pfizer-BioNTech vaccine found its effectiveness fell to 74% five or six months after receiving both doses.

Source: Yahoo News