Pfizer planned to seek US authorization for COVID-19 booster shot.
Pfizer Inc planned to ask regulators in the United States to authorize a booster shot of its COVID-19 vaccine within the next month.
On Thursday, the drugmaker’s top scientist said that based on evidence of greater risk of coronavirus reinfection six months after vaccination and the spread of the highly contagious Delta COVID-19 variant, Pfizer planned to ask US regulators to authorize a booster shot of its COVID-19 vaccine within the next month.
However, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) said in a joint statement that Americans who had been fully vaccinated don’t need a COVID-19 booster shot at the time.
Also, some scientists have questioned the need for COVID-19 booster shots.
Pfizer’s chief scientific officer Mikael Dolsten said that the recently reported dip in the effectiveness of the said vaccine in Israel was mostly because of coronavirus infections in people who had been inoculated in January or February.
The country’s health ministry said that vaccine effectiveness in preventing both coronavirus infection and symptomatic disease fell to 64 percent in June.
Pfizer didn’t release the full set of Israeli data on Thursday, but said that it would be published soon.
“It’s a small data set, but I think the trend is accurate: Six months out, given that Delta is the most contagious variant we have seen, it can cause infections and mild disease,” Dolsten said.
In a joint statement, the FDA and CDC said that they’re prepared for COVID-19 booster shots if and when the science demonstrated that they’re needed.
“The United States is fortunate to have highly effective vaccines that are widely available for those aged 12 and up. People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta. People who are not vaccinated remain at risk. Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated. We encourage Americans who have not yet been vaccinated to get vaccinated as soon as possible to protect themselves and their community,” the CDC and FDA said in the statement.
Dolsten said that Pfizer’s own data from the United States showed an erosion of the efficacy of the said vaccine to the mid-80s after six months against the COVID-19 variants circulating there in the spring.
He also stressed that data from Israel and Britain suggested that the said vaccine remained around 95% effective against severe disease even with waning antibody levels.