Pfizer submits initial data for COVID-19 vaccine recall authorization



[ad_1]

(Reuters) -Pfizer Inc and its German partner BioNTech SE have submitted initial data from a preliminary trial to U.S. regulators to seek authorization for a booster dose of their COVID-19 vaccine, manufacturers said on Monday. of drugs.

They stated that the third dose showed significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus compared to the two doses as well as against the highly infectious beta and delta variants.

Pfizer said its vaccine’s effectiveness worsened over time, citing a study that showed 84% effectiveness compared to a peak of 96% four months after a second dose. Some countries, including Israel, have already implemented plans to administer booster doses.

However, the decision of a few wealthy countries to purchase recalls has angered health activists and the World Health Organization, which has called for a moratorium on recalls until at least the end of September.

Pfizer and BioNTech had said that all patients in the trial received the third injection, BNT162b2, eight to nine months after their second dose.

Drugmakers will submit trial data to the European Medicines Agency and other regulatory authorities in the coming weeks. They said results from an advanced third-dose trial are expected shortly.

Last week, U.S. regulators cleared a third dose of COVID-19 vaccines by Pfizer-BioNTech and Moderna Inc for people with weakened immune systems who are likely to have weaker protection against two-dose regimens. .

(Reporting by Mrinalika Roy in Bengaluru; Editing by Sriraj Kalluvila and Arun Koyyur)

[ad_2]

Source link