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Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

Pfizer and BioNTech will seek a new authorisation for a third booster dose of their COVID-19 vaccine from the US Food and Drug Administration according to reports.

Pfizer’s chief medical officer Mikael Dolsten reportedly told The Associated Press that preliminary data from the company’s vaccine booster study indicates that antibodies increase five- to ten-fold following a third dose of its BioNTech-partnered jab, compared to after a second dose.

He added that Pfizer is expecting to submit a request to the FDA for an emergency use authorisation (EUA) for the booster dose in August.

However, even if the booster dose is approved, it may not immediately mean that individuals will be offered a third jab.

In a joint statement issued this week, the FDA and US Centers for Disease Control said that “Americans who have been fully vaccinated do not need a booster shot at this time”.

The agencies added that those who are fully vaccinated are still protected from severe illness and disease caused by COVID-19 variants  - including the highly transmissible Delta variant.

Recently published findings from Israel’s Health Ministry suggests that Pfizer/BioNTech’s COVID-19 vaccine is less effective against the Delta variant.

New real-world data, collected over the last month, suggests the jab is 64% effective at preventing infection after both doses, following the emergence of the Delta variant.

The newly reported figures still suggest, however, that the Pfizer/BioNTech vaccine is 93% effective against severe COVID-19 and hospitalisation.

In Israel, COVID-19 cases have been steadily growing since all restrictions were lifted on 1 June, with the Delta variant thought to be causing a surge in infections. Approximately 57% of Israel’s general population are fully vaccinated, with 88% of individuals over the age of 50 years having had two doses.

Although the variant is thought to be more transmissible than the original COVID-19 strain, there is currently little evidence that it leads to more severe disease.

Additional data from a study conducted by Public Health England (PHE) found that the Pfizer/BioNTech vaccine was 96% effective against hospitalisation or death caused by the Delta variant following two doses.

In addition, lab studies published last month found the antibodies produced by Pfizer/BioNTech’s vaccine neutralised all variants tested, including the Delta variant.

Article by
Lucy Parsons

9th July 2021

From: Regulatory



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