US pharma giant Pfizer to seek nod for 3rd booster dose of COVID-19 vaccine

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American pharma giant Pfizer and its German partner  BioNTech announced on Thursday that they plan to ask U.S. and European regulators to authorize a third booster dose of their COVID-19 vaccine to further increase protection against coronavirus, especially the more contagious new Delta variant spreading across the world.</p>
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However, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) said in a joint statement that Americans who have been fully vaccinated do not need a booster COVID-19 shot at this point.</p>
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Reuters news agency has in its report from New York has also cited scientists who have questioned the need for booster shots.</p>
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<strong>Also read:</strong>  <a href="https://www.indianarrative.com/health-news/us-pharma-giant-pfizer-keen-to-export-vaccine-to-india-but-there-s-a-rider-90942.html">US pharma giant Pfizer keen to export vaccine to India but there’s a rider</a></p>
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Pfizer's chief scientific officer, Mikael Dolsten, said the decline in the vaccine's effectiveness in Israel reported recently was mainly due to infections in people who had been vaccinated in January or February. Israel’s health ministry said the efficacy of the vaccine in preventing the infection fell to 64% in June.</p>
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"The Pfizer vaccine is highly active against the Delta variant. But after six months there is the likely risk of reinfection as antibodies wane." Data would be submitted to the FDA within the next month, Dolsten said.</p>
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Pfizer did not release the entire Israeli data on Thursday, but said it would be published soon.</p>
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The FDA and CDC, in their joint statement, said: "We are prepared for booster doses if and when the science demonstrates that they are needed."</p>
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<strong>Also read:</strong>  <a href="https://www.indianarrative.com/health-news/india-may-get-million-doses-of-pfizer-moderna-vaccines-from-who-led-covax-facility-100807.html">India may get 4 million doses of Pfizer, Moderna vaccines from WHO-led COVAX facility</a></p>
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Pfizer's own data from the United States showed a drop in the vaccine's efficacy from 95% to around 85% after six months, Dolsten said.</p>
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At the same time he claimed data from Israel and Britain indicates that even with falling antibody levels, the vaccine remains around 95% effective against severe disease.</p>
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Dolsten said early data from the company's own studies shows that a third booster dose generates antibody levels that are five-to-10-fold higher than after the second dose, suggesting that a third dose will offer more protection.</p>
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However, Reuters cited Dr. Eric Topol, a professor of molecular medicine and director of the Scripps Research Translational Institute in as saying that “basing the decision on waning antibody protection ignores the role of important other parts of the immune response, including memory B cells, which can make antibodies on demand when challenged by the virus.”</p>
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"You need better studies to be able to assert that. It isn't just neutralizing antibodies," Topol said.</p>
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<strong>BIG MONEY</strong></p>
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The financial stakes for Big Pharma are high which is why they have been fighting against the India-South Africa proposal for a temporary waiver on patent rights so that more vaccines can be produced in other countries to meet the acute shortage of doses worldwide.</p>
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Pfizer has already projected COVID-19 vaccine sales to be around $26 billion in 2021. Global spending on COVID-19 vaccines and booster shots is expected to touch a phenomenal $157 billion till 2025, according to U.S. health data firm IQVIA Holdings.</p>