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BioNTech and Pfizer provide the FDA with data for regulatory approval



BioNTech and Pfizer

A preliminary set of data from BioNTech and Pfizer has been submitted to the US Food and Drug Administration in order to permit the use of a booster dose of the COVID-19 vaccine.

When compared to those who got two doses, those who received the booster dosage developed a significantly greater antibody response against coronavirus variants such as the Delta and Beta versions.

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The booster dose appeared to provide protection against both the Delta and Beta versions of the coronavirus, as well as the original coronavirus, according to the results.

Given the high levels of immune responses observed, a booster dosage administered within six to twelve months after the first immunization schedule may be beneficial in maintaining a high degree of protection against COVID-19, according to the business.

“Based on these preliminary findings, we believe that with the third dosage of our vaccine, we may be able to maintain and perhaps improve upon the high levels of protection against the wild-type virus and relevant variants,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech.

The use of a booster vaccination could help to lower infection and sickness rates in persons who have already been vaccinated, as well as to better manage the spread of virus variations during the upcoming flu season.

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The release of the data on booster doses coincides with an increase in COVID-19 cases and hospitalizations, particularly among the unvaccinated in the southern United States.

Pfizer executives believe that a booster dosage will be required in the near future, but US health officials argue that no evidence has been produced to support this.

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