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Pfizer asks to be licensed for booster doses of vaccine as Delta variant spreads

On Thursday, Pfizer’s top scientist announced that the pharmaceutical company is planning to ask US regulators to authorize a booster dose (a booster dose) of the vaccine. – ask for COVID-19,based on evidence of a higher risk of reinfection after 6 months of vaccination as well as the uncontrolled spread of the Delta (India) variant.

However, in a joint announcement, the US Food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC) stated that Americans who have been fully immunized No booster dose of COVID-19 vaccine is required at this time.

Some scientists also question the need for booster injections.

Mikael Dolsten, Pfizer’s chief scientific officer, said the recent drop in vaccine efficacy reported in Israel was mainly due to infection among people who were vaccinated in January or February.

According to the Israeli Ministry of Health, the vaccine’s effectiveness in preventing infection and symptomatic infection fell to 64% in June.

“The Pfizer vaccine is highly effective against the Delta variant,” Dolsten said in an earlier interview. However, six months later, he said again, “there is a possibility of reinfection when the antibodies weaken as expected.”

The Pfizer vaccine, developed in conjunction with German partner BioNTech, was found to be 95% effective in preventing symptomatic COVID-19 infection in a series of clinical trials these companies conducted in 2016. last.

According to Mr. Dolsten, initial data from the company’s own studies show that the third booster dose produces 5 to 10 times higher antibody levels than the second dose, suggesting that the A third injection will provide promising protection.

Many countries in Europe and elsewhere have been in contact with Pfizer to discuss booster doses, Dolsten said, adding that some countries may start administering booster doses before they do. allowed in the United States.

Mr. Dolsten believes booster doses of the vaccine are especially important for older populations.

Dr. Eric Topol, a professor of molecular medicine and director of the Scripps Research Translational Institute in La Jolla, California, also recognizes that decision-making based on impaired antibody protection ignores Other key elements of the immune response, including memory B cells, can produce antibodies on demand when challenged by a virus.

“We need further studies to confirm that,” Topol said. It is not just a matter of neutralizing antibodies.”
Pfizer has previously said it’s more likely that people will need a booster shot, although some scientists have questioned when or whether booster shots are needed.

Pfizer plans to soon conduct a placebo-controlled clinical trial of the booster injection with the participation of 10,000 people. That study will run through the fall, according to Dolsten, which means it won’t be completed before the company has filed for approval with the FDA.

Dr. William Schaffner, a vaccine expert at Vanderbilt University Medical Center believes that, even if a booster dose of Pfizer’s vaccine is approved by the FDA for use, it is only the first step. . This booster dose still needs to be reviewed and recommended by CDC advisors.

Because the booster dose will increase the demand for the vaccine while much of the world remains unvaccinated, Mr. Dolsten said Pfizer is looking for ways to boost production.

Pfizer has set a target of producing 3 billion doses this year and 4 billion doses next year. Dolsten declined to say exactly how many more doses Pfizer could add, but said: “We could add billions of doses by 2022.”

Dolsten also revealed that Pfizer and BioNTech are working on a new version of the vaccine that targets the Delta variant. However, these companies do not believe that the current version of the Pfizer vaccine will need to be replaced to protect against this strain.

Pfizer expects the COVID-19 vaccine to be a major source of revenue for many years and has predicted sales of the vaccine in 2021 at $26 billion. According to IQVIA Holdings, a US health data business, global spending on COVID-19 vaccines and boosters could total $157 billion by 2025.

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