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Next on the FDA’s agenda: Modern, Johnson & Johnson vaccine booster shots.

WASHINGTON (AP) – Many Americans who have received the Pfizer vaccine are already rolling up their sleeves for a booster shot, along with millions of others. Modern Or Johnson & Johnson. Vaccines are anxiously awaiting to know when it is their turn.

Federal regulators begin to address this question this week.

On Thursday and Friday, Department of Food and Medicine It calls on its independent advisers for the first step in the decision-making process on whether to distribute additional doses of the two vaccines and if so, who will receive them and when. Final progress is not expected for at least a week.

after the FDA As advisors recommend, the agency itself will make a formal decision on whether to authorize the boosters. Then next week, a panel from the Centers for Disease Control and Prevention will provide more details on who should get them. This decision is subject to the approval of the CDC Director.

The purpose of this process is to increase public confidence in the safety and effectiveness of vaccines. But it has already caused controversy and disagreement between various experts and agencies.

For example, last month the CDC Advisory Panel supported Pfizer Booster over a six-month period for older Americans, nursing home residents and people with basic health problems. But CDC Director Dr. Rochelle Valensky dismissed his advisers and decided that the boosters should also be offered to those who include teachers and healthcare workers, adding millions more to the list. Has been added.

Some health experts fear that back-and-forth deliberations are undermining public efforts to persuade unsafe people to get their first shots. He worries that the booster talk will lead people to mistakenly doubt the effectiveness of the vaccine.

As FDAPanel meeting to review Modern And J&J Vaccine, this time its decision is likely to be even more complicated, experts are debating whether a third. Modern The shot should contain only half of the actual dose and what is the best time for the second shot of the single dose. J&J Vaccine

The first two. Modern Each of the shots contains 100 micrograms of vaccine. But the drug maker says 50 micrograms should be enough for healthy people.

A study of 344 people at the company gave them 50 microgram shots six months after the second dose and the levels of antibodies fighting the virus jumped. Modern He said the booster increased antibodies 42-fold, which is capable of targeting additional infectious delta species.

Side effects were similar to fever and pain. Modern The company said recipients usually experiment after their second regular shot.

As far as the people who are concerned J&J Vaccine, the company submitted the data FDA For different options: Booster shot in two months or six months. The company did not indicate its preference.

J&J Figures released in September show that a two-month booster provides 94% protection against moderately severe COVID-19 infections. The company has not yet released patient data on the six-month booster, but early steps of antibodies fighting the virus show that it provides even more protection.

Even without a booster, J&J The vaccine is said to be about 80% effective in preventing COVID-19 from entering hospitals in the United States.

An estimated 103 million Americans have been fully vaccinated with the Pfizer formula, with 69 million. ModernWith K and 15 million. J&JAccording to the CDC.

Scientists emphasize that all three vaccines used in the United States still provide strong protection against severe disease and death from COVID-19. The problem is how quickly, and how often, protection against mild infections can be lost.

In a recent study, researchers compared about 14,000 people who got their first. Modern Eight months ago with a dose of 11,000 vaccines a year ago. As Delta’s form increased in July and August, the rate of “breakthrough” infection in the most recently vaccinated group was 36 lower than that previously vaccinated.

Still, medical experts continue to debate the science and justification for giving extra shots to people who already have significant protection.

The White House and its top medical advisers announced in August major plans to offer booster to almost all adults, highlighting the declining security and the growing Delta variant of the time. But he was denied by many experts who said there were few figures to show whether such widespread use would stop breakthrough infections or slow down the overall pace of affairs. ۔

While FDA And the CDC eventually reduced the use of Pfizer boosters, with Biden administration officials, including Dr. Anthony Fookie, suggesting that additional shots would eventually be recommended for most Americans.

He points to Israeli statistics showing a low rate of infection and severe illness among those who received a third Pfizer shot.

Of FDA The appointments come as US vaccinations averaged more than 1 million a day, an increase of more than 50 percent over the past two weeks. This increase is mainly due to Pfizer boosters and employer vaccine mandates.

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The Associated Press Health and Science Department is supported by the Department of Science Education at Howard Hughes Medical Institute. The AP is fully responsible for all content.

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