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Pfizer seeks FDA approval for third vaccination – News


Video Source: YouTube, CNBC TV

By Lauran Neergaard

Pfizer is seeking US approval for a third dose of the COVID-19 vaccine. On Thursday, another injection within 12 months could dramatically boost immunity and help prevent the latest coronavirus variants of concern.

Studies from multiple countries show that Pfizershot and other widely used COVID-19 vaccines are rapidly spreading worldwide and are now highly contagious, causing most new US infections. It provides strong protection against delta mutants.

Two doses of most vaccines are important for developing antibodies that fight high levels of the virus against all versions of the coronavirus, not just the delta variant. ..

However, antibodies naturally decline over time, so research is underway to determine if and when boosters are needed.

On Thursday, Pfizer’s Dr. Michael Dorsten told The Associated Press that early data from the company’s booster study suggests that people’s antibody levels jump 5-10 times after the third dose. ..

Pfizer will seek an emergency permit from the Food and Drug Administration for a third dose in August, he said.

Why is it important to fight the Delta Variant? Dorsten pointed out data from the United Kingdom and Israel showing that the Pfizer vaccine “neutralizes delta mutants very well.” According to him, there is an assumption that if the antibodies are low enough, the delta virus can eventually cause a mild infection before the immune system recovers.

However, FDA approval is only the first step. It does not automatically mean that Americans will be offered boosters, warned Dr. William Schaffner, a vaccine expert at Vanderbilt University Medical Center. Public health authorities will have to decide if they are really needed, especially since millions of people are unprotected.

“The vaccine was designed to keep us away from the hospital,” he said, and continues to do so despite the more contagious delta mutants. Giving another dose would be “a great deal of effort while we are currently striving to give people the first dose.”

Currently, only about 48% of the US population is fully vaccinated. Also, in some parts of the country, immunization rates are much lower and delta variants are skyrocketing. On Thursday, Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, said that would lead to “two truths.” The highly immunized band in the United States is returning to normal while hospitalizations are increasing elsewhere.

“This spike is a nuisance,” she said. A few weeks ago, delta variants accounted for just over a quarter of new cases in the United States, but now account for just over 50%. , 80%.

Also on Thursday, researchers at the Pasteur Institute in France reported new evidence that complete vaccination is important.

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In clinical tests, the team reported to the journal Nature that the blood of dozens of people who received the first dose of the Pfizer or AstraZeneca vaccine “little” inhibited the delta mutant. However, weeks after receiving the second dose, almost all researchers found an immune boost strong enough to neutralize the delta mutant, even if it was slightly less potent than previous versions of the virus. Had

French researchers also tested unvaccinated people who survived a coronavirus attack and found that their antibodies were one-quarter potent against the new mutants. However, studies have shown that a single dose of the vaccine dramatically increased antibody levels, triggering cross-protection against the delta and two other mutants. This supports the public health recommendation that COVID-19 survivors be vaccinated rather than relying on innate immunity.

Lab experiments add real-world data that delta variant mutations do not evade the most widely used vaccines in Western countries, but before the virus evolves further, more world It emphasizes the importance of immunization.

For example, two doses of Pfizer vaccine have been found to be 96% protective against hospitalization for delta mutations and 88% effective against symptomatic infections, British researchers have found. The finding was repeated by Canadian researchers last weekend, but reports from Israel suggested that protection against mild delta infections could have dropped to 64%.

Whether fully vaccinated ones still need to wear masks where delta mutants are proliferating is becoming an increasingly questionable. In the United States, the CDC argues that fully vaccinated people do not need to do so. Vaccines were not perfect even before the advent of the delta mutant, but the best evidence suggests that if vaccinated people are infected with the coronavirus, they will be in much milder cases. doing.

“I emphasize that if you get vaccinated, you get a very high degree of protection,” said Dr. Anthony Fauci, the best infectious disease expert in the US government, Thursday.

Warrensky said Thursday that case rates have risen in the United States for several weeks and hospitalization rates have begun to rise, up 7% from the previous seven-day average. However, deaths continue to decline on average, with some experts attributed, at least in part, to the high immunization rates of people over the age of 65, who are most susceptible to severe illness. thinking about.

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The Associated Press writer Mike Stob contributed to the story.

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Source: Associated Press, CNBC TV



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