Wichita, Kansas 2021-10-12 10:45:19 –
Washington (AP) — Many Pfizer-vaccinated Americans have already rolled up their sleeves for booster shots, so millions of people who received the Moderna or Johnson & Johnson vaccines are in their turn Waiting anxiously to learn when.
Federal regulators will begin addressing the issue this week.
On Thursday and Friday, the Food and Drug Administration will convene independent advisors at the beginning of the process of deciding whether to give two additional vaccines, and if so, who and when. The final go-ahead is not expected for at least another week.
After the FDA advisor makes the recommendation, the FDA itself decides whether to approve the booster. Then next week, a panel convened by the Centers for Disease Control and Prevention will provide more details on who should get them. The decision requires approval by the CDC Director.
This process aims to increase public confidence in vaccines. However, it has already caused conflicts and disagreements among experts and institutions.
For example, last month, the CDC Advisory Board assisted Pfizer boosters at six months for older Americans, nursing home residents, and people with underlying health problems. However, CDC director Dr. Rochelle Walensky dismissed her adviser and decided to provide boosters to high-risk jobs such as teachers and healthcare professionals, tens of millions. Added people Americans to the list.
Some health professionals fear that pre- and post-discussion has confused public efforts to convince unvaccinated individuals to take their first shot. They are worried that the story of boosters could mislead people into doubting the effectiveness of the vaccine in the first place.
This decision can be further complicated when the FDA panel meets with Moderna to consider the J & J vaccine, and whether experts should include only half of the original dose in the third Moderna shot. And what is the best timing for the second shot? A single dose of J & J vaccine.
The panel will also consider the safety and efficacy of mixing and adapting different brands of vaccines that have not been previously approved by regulatory agencies.
According to the CDC, an estimated 103 million Americans have been fully vaccinated with Pfizer’s prescription, 69 million have been vaccinated with Moderna, and 15 million have been vaccinated with J & J. Regulators first addressed the Pfizer booster issue as the company submitted the data ahead of other vaccine manufacturers.
The two first Moderna shots each contain 100 micrograms of vaccine. But pharmaceutical companies say 50 micrograms should be enough for boosters for healthy people.
In a company study of 344 people, 50 micrograms of shots were given 6 months after the second dose, resulting in a surge in levels of antibodies that fight the virus. According to Moderna, the booster even caused a 42-fold increase in antibodies that could target the highly contagious delta mutant.
According to the company, the side effects were similar to the fever and pain that Moderna recipients typically experience after a second normal shot.
For those who received the J & J vaccine, the company submitted data to the FDA on various options. A 2 or 6 month booster shot. The company didn’t show that preference.
J & J released data in September showing that boosters given in two months provide 94% protection against moderate to severe COVID-19 infections. The company has not yet disclosed patient data on a 6-month booster, but early measures against the virus-fighting antibody suggest that it provides even higher protection.
Even without a booster, the vaccine is about 80% effective in preventing COVID-19 hospitalization in the United States, according to J & J.
Scientists emphasize that all three vaccines used in the United States still provide strong protection against serious illness and death from COVID-19. The question is how quickly and how weak the defense against mild infections can be.
In a recent study, researchers compared about 14,000 people who received their first moderna vaccination a year ago with 11,000 people who were vaccinated eight months ago. Due to the surge in delta variants in July and August, recently vaccinated groups had a 36% lower incidence of “breakthrough” infections compared to previously vaccinated groups.
Still, medical professionals continue to discuss the science and rationale for giving additional shots to those who already have significant protection.
The White House and its top medical advisers announced in August a drastic plan to provide boosters to almost all adults, citing signs of declining protection and a subsequent surge in Delta variants. .. However, they were rejected by many experts who stated that there was little data showing whether such widespread use would prevent breakthrough infections or suppress the overall trajectory of the case.
The FDA and CDC eventually reduced the use of Pfizer boosters, but officials from the Biden administration, including Dr. Anthony Fauci, eventually suggested that most Americans would be encouraged to take additional shots. I am.
They point to Israeli data showing low infection rates and low incidence of serious illness in people who receive a third Pfizer shot.
The FDA’s meeting is held because US vaccinations averaged over 1 million per day and increased by more than 50% in the last two weeks. This rise has been driven primarily by Pfizer boosters and employers’ vaccination obligations.
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