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Pfizer submits initial trial data to FDA for COVID-19 vaccine booster


BREAKING NEWS: Pfizer submits initial trial data to FDA for COVID-19 vaccine booster that showed third dose increased antibody levels against Indian ‘Delta’ variant compared to two doses

  •  Pfizer and BioNTech submitted initial clinical trial data of a third COVID-19 vaccine shot to the FDA
  • Data showed the booster shots elicit high antibody responses against the Indian ‘Delta’ variant and the South African ‘Beta’ variant

Pfizer and BioNTech have submitted initial clinical trial data for their joint COVID-19 vaccine booster shot to the U.S. Food and Drug Administration (FDA).

The data show that the booster shots elicit high antibody responses, and can be particularly effective against the Indian ‘Delta’ variant and the South African ‘Beta’ variant.

Pfizer recommends a third dose be administered to a person six to twelve months after receiving the second dose.  

It comes just a few days after the FDA approved third doses of the Pfizer or Moderna vaccine to immunocompromised people. 

Pfizer and BioNTech submitted initial clinical trial data of a third COVID-19 vaccine shot to the FDA. Pictured: A nurse prepares a shot of the Pfizer vaccine, August 2021

‘Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable,’ said Pfizer CEO Albert Bourla in a statement.

‘Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus.

‘The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule. 

‘We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic.’ 

Participants in the study were found to have an increase in antibody levels when receiving the third dose nine months after receival of the second. 

Recipients of the vaccine of all ages were found to develop specific antibodies that are effective against the Beta or Delta variants.

‘We continuously strive to stay at least one step ahead of the virus,’ said Dr Ugur Sahin, CEO and Co-founder of BioNTech in a statement.

‘This is why we aim to expand access to our vaccine for people around the world and are working on various approaches as part of our comprehensive strategy to address the virus and its variants today as well as in the future,’ 

‘This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine. 

‘A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season.’

Pfizer first unveiled data for the company’s vaccine booster dose at the end of July.

In the slides published online, the researchers wrote there there is ‘estimated potential for up to 100-fold increase in Delta neutralization post-dose three compared to pre-dose three.’ 

The company also revealed last month that its vaccine’s efficacy falls from 96 percent to 84 percent six months after receival.

With the vaccine first rolling out in December, many early adopters of the vaccine may have already had some of their immunity to COVID-19 be decreased.

The booster shot’s effectiveness against the Delta variant comes at a welcome time, as the highly contagious strain of the virus runs rampant throughout the United States.

Currently, the United States is recording over 130,000 new cases every day – a total not previously reached since the worst virus surge that country experienced in February. 

With numbers rapidly rising, increasing over 550 percent from the start of July – when less than 20,000 cases were being recorded every day.

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