Pfizer and its partner, BioNTech, will seek emergency authorization from the U.S. Food and Drug Administration for a second booster shot of their COVID-19 vaccine for people 65 and older, The Washington Post is reporting.
Pfizer says it hopes the shot will boost waning immunity that studies have shown occurs four to five months after the first booster, according to three people the Post described as familiar with the situation.
Neither Pfizer nor the FDA would comment to the Post on a request for authorization for a fourth dose for those over age 65.
However, Pfizer’s CEO Albert Bourla said Sunday that a fourth dose of the company’s COVID-19 vaccine will be needed by all adults to bolster the immune system to be able to fight off other variants of the virus that will inevitably come in the months and years ahead.
“Many variants are coming, and Omicron was the first one that was able to evade — in a skillful way — the immune protection that we’re giving,” Albert Bourla told CBS’ “Face the Nation.”
“The protection we are getting from the third (dose) it is good enough — actually quite good for hospitalizations and deaths,” Bourla said.
According to Bourla, a fourth dose is needed because protection against the disease after three doses is “not that good against infections” and “doesn’t last very long” when new variants such as omicron emerge.
“It is necessary, a fourth (dose) for right now,” Bourla said.
The submission to the FDA could include a study of cases collected in Israel, the unnamed source told the Post.
One study out of Israel showed that people 60 and older who received a fourth shot saw rates of infection that were lower after the fourth dose. The rates of severe illness were substantially lower in people who received a fourth shot, according to study results.
The FDA fully approved Pfizer’s COVID-19 vaccine in August, and a third dose of Pfizer’s vaccine was granted emergency use authorization for those ages 12 and older.