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Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.
If the request is approved, He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.
Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.
This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.
However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.
The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.
The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.
The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
A version of this article first appeared on WebMD.com.
Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.
If the request is approved, He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.
Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.
This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.
However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.
The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.
The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.
The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
A version of this article first appeared on WebMD.com.
Pfizer and its European partner BioNTech on Nov. 9 asked the U.S. government to expand emergency use authorization (EUA) to allow everybody over 18 to receive their COVID-19 booster shots.
If the request is approved, He announced the goal last August but backed off after some scientists said younger people may not need boosters, especially with large parts of the world unvaccinated.
Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to The Associated Press.
This would be Pfizer’s second attempt. In September, a Food and Drug Administration advisory panel turned down Pfizer’s idea of booster shots for everybody over 18.
However, the committee recommended Pfizer booster shots for people 65 and over, essential workers, and people with underlying health conditions.
The FDA and the Centers for Disease Control and Prevention authorized the Pfizer booster for those other groups and later authorization was granted for the same groups with Moderna and Johnson & Johnson boosters. People who got the two-shot Pfizer or Moderna vaccines should get a booster 6 months after the second dose and people who got the one-dose J&J vaccine should get a booster 2 months later.
The pro-booster argument has strengthened because new data have come in from Israel that confirm boosters provide protection as vaccine effectiveness wanes over time, The Washington Post reported. Also, health officials are worried about a post-holiday surge and because COVID-19 case counts and deaths are not dropping in every part of the country, though they are declining overall, according to the The Post report.
The regulatory path for a booster-for-all application is unclear. The Post, citing two unnamed officials, said the FDA probably won’t send the Pfizer application to the FDA advisory committee this time because the committee has already had extensive discussions about boosters. If the FDA gives the green light, CDC Director Rochelle Walensky, MD, would have to make updated recommendations on boosters, The Post article noted.
A version of this article first appeared on WebMD.com.