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Pfizer submits data for 3rd dose approval in US

Pfizer and BioNTech presented the results of their Phase One trial that evaluated the safety and efficacy of a third shot.

August 17, 2021 / 17:08 IST

Pfizer and BioNTech on Monday submitted preliminary clinical data to US health authorities as part of their effort to seek authorization for a third dose of their Covid-19 vaccine for all Americans.

Last week, the United States approved the booster shot of Pfizer-BioNTech and Moderna vaccines for people with weakened immune systems.

Pfizer and BioNTech presented the results of their Phase One trial that evaluated the safety and efficacy of a third shot.

"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," Albert Bourla, Pfizer's Chairman and Chief Executive Officer, said in a statement.

"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," said BioNTech Co-founder Ugur Sahin.

COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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The companies plan to submit the same information to European authorities in the coming weeks.

The move comes despite appeals by the World Health Organization for a moratorium on booster shots to help ease the drastic inequity in dose distribution between rich and poor nations. Israel has also began administering third doses to its citizens.

An advisory committee of the Centers for Disease Control and Preventions, a top US healthcare agency, is slated to meet in late August to discuss the approval of a third dose of the vaccine for adults over 65, care home residents and healthcare workers.

Follow our full coverage of the coronavirus pandemic here.

AFP
first published: Aug 17, 2021 05:08 pm

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