Next on the FDA’s agenda: Booster shots for modern, J&J vaccines
With many Americans who have received the Pfizer vaccination already rolling up their sleeves for a booster shot, millions of others who have received either Moderna or Johnson & Johnson vaccines wait anxiously to find out when it’s their turn. Is.
Federal regulators begin tackling that question this week.
On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first step in the process of deciding whether additional doses of the two vaccines should be given and if so, who should receive them and when. Final approval is not expected for at least another week.
After FDA advisors make their recommendation, the agency will decide for itself whether to authorize the booster. Then next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics about who should get them. Its decision is subject to approval by the CDC director.
This process is to increase public confidence in vaccines. But it has already created conflict and disagreement among experts and agencies.
For example, last month the CDC advisory panel endorsed a Pfizer booster at the six-month point for older Americans, nursing home residents, and people with underlying health problems. But CDC Director Dr. Rochelle Valensky dismissed her advisors and decided that boosters should also be offered to people with high-risk jobs such as teachers and health care workers, adding millions more Americans to the list.
Some health experts fear that back-and-forth discussions are spoiling a public effort to persuade non-vaccinated people to get their first shot. He worries that talk of boosters will lead people to falsely doubt the effectiveness of vaccines in the first place.
As the FDA’s panel meets to review Moderna and J&J vaccines, its decision is likely to be even more complicated, this time with experts discussing whether the third Moderna shot should contain only half of the original dose and replace it with the second shot. What is the best time for Single-dose J&J Vaccine.
The panel will also look into the safety and effectiveness of mixing and matching different brands of vaccines, something regulators have not endorsed so far.
According to the CDC, an estimated 103 million Americans have been fully vaccinated with Pfizer’s formula, 69 million with Moderna, and 15 million with J&J. Regulators first raised the question of Pfizer Booster because the company submitted its data before other vaccine makers.
The two initial Moderna shots each contain 100 micrograms of the vaccine. But the drugmaker says 50 micrograms should be enough for a booster for healthy people.
One company study of 344 people who gave them a 50-microgram shot six months after their second dose found a jump in the levels of virus-fighting antibodies. Moderna said the booster triggered a 42-fold increase in antibodies capable of targeting the extra-infectious delta variant.
Side effects were similar to the fever and pain that Moderna recipients typically experience after their second regular shot, the company said.
For people getting the J&J vaccine, the company submitted data to the FDA for different options: a booster shot at two months or six months. The company did not indicate its preference.
J&J released data in September showing that boosters given over two months provided 94% protection against moderate to severe COVID-19 infections. The company has yet to disclose patient data on the six-month booster, but early measures of virus-fighting antibodies suggest it offers even greater protection.
Even without boosters, J&J says, its vaccine is about 80% effective in preventing COVID-19 hospitalizations in the US
Scientists emphasize that all three vaccines used in the US still offer strong protection against serious illness and death from COVID-19. The issue is how quickly and how little protection against minor infections can be.
In a recent study, researchers compared nearly 14,000 people who received their first Moderna dose a year ago to 11,000 who had received the vaccine eight months earlier. As the delta variant increased in July and August, the recently vaccinated group had a 36% lower rate of “breakthrough” infection, compared to the previously vaccinated group.
Still, medical experts continue to debate the science and rationale for giving those extra shots to people who already have significant protection.
The White House and its top medical advisers announced sweeping plans in August to offer boosters to nearly all adults, citing dwindling signs of safety and the then-rising delta variant. But he was rebuffed by several experts, who said there was little data showing whether such widespread use would stop breakthrough infections or curb the overall trajectory of cases.
While the FDA and CDC eventually decriminalized the use of Pfizer boosters, Dr. Biden administration officials, including Anthony Fauci, have suggested additional shots will eventually be recommended for most Americans.
They point to data from Israel showing a low rate of infection and severe illness among people who received a third Pfizer shot.
The FDA meetings come as the US vaccination average has climbed above 1 million per day, a more than 50% increase in the past two weeks. Growth has been primarily driven by the Pfizer booster and employer vaccine mandates.
Next on the FDA’s agenda: Booster shots for modern, J&J vaccines
Next on the FDA’s agenda: Booster shots for modern, J&J vaccines
With many Americans who have received the Pfizer vaccination already rolling up their sleeves for a booster shot, millions of others who have received either Moderna or Johnson & Johnson vaccines wait anxiously to find out when it’s their turn. Is.
Federal regulators begin tackling that question this week.
On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first step in the process of deciding whether additional doses of the two vaccines should be given and if so, who should receive them and when. Final approval is not expected for at least another week.
After FDA advisors make their recommendation, the agency will decide for itself whether to authorize the booster. Then next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics about who should get them. Its decision is subject to approval by the CDC director.
This process is to increase public confidence in vaccines. But it has already created conflict and disagreement among experts and agencies.
For example, last month the CDC advisory panel endorsed a Pfizer booster at the six-month point for older Americans, nursing home residents, and people with underlying health problems. But CDC Director Dr. Rochelle Valensky dismissed her advisors and decided that boosters should also be offered to people with high-risk jobs such as teachers and health care workers, adding millions more Americans to the list.
Some health experts fear that back-and-forth discussions are spoiling a public effort to persuade non-vaccinated people to get their first shot. He worries that talk of boosters will lead people to falsely doubt the effectiveness of vaccines in the first place.
As the FDA’s panel meets to review Moderna and J&J vaccines, its decision is likely to be even more complicated, this time with experts discussing whether the third Moderna shot should contain only half of the original dose and replace it with the second shot. What is the best time for Single-dose J&J Vaccine.
The panel will also look into the safety and effectiveness of mixing and matching different brands of vaccines, something regulators have not endorsed so far.
According to the CDC, an estimated 103 million Americans have been fully vaccinated with Pfizer’s formula, 69 million with Moderna, and 15 million with J&J. Regulators first raised the question of Pfizer Booster because the company submitted its data before other vaccine makers.
The two initial Moderna shots each contain 100 micrograms of the vaccine. But the drugmaker says 50 micrograms should be enough for a booster for healthy people.
One company study of 344 people who gave them a 50-microgram shot six months after their second dose found a jump in the levels of virus-fighting antibodies. Moderna said the booster triggered a 42-fold increase in antibodies capable of targeting the extra-infectious delta variant.
Side effects were similar to the fever and pain that Moderna recipients typically experience after their second regular shot, the company said.
For people getting the J&J vaccine, the company submitted data to the FDA for different options: a booster shot at two months or six months. The company did not indicate its preference.
J&J released data in September showing that boosters given over two months provided 94% protection against moderate to severe COVID-19 infections. The company has yet to disclose patient data on the six-month booster, but early measures of virus-fighting antibodies suggest it offers even greater protection.
Even without boosters, J&J says, its vaccine is about 80% effective in preventing COVID-19 hospitalizations in the US
Scientists emphasize that all three vaccines used in the US still offer strong protection against serious illness and death from COVID-19. The issue is how quickly and how little protection against minor infections can be.
In a recent study, researchers compared nearly 14,000 people who received their first Moderna dose a year ago to 11,000 who had received the vaccine eight months earlier. As the delta variant increased in July and August, the recently vaccinated group had a 36% lower rate of “breakthrough” infection, compared to the previously vaccinated group.
Still, medical experts continue to debate the science and rationale for giving those extra shots to people who already have significant protection.
The White House and its top medical advisers announced sweeping plans in August to offer boosters to nearly all adults, citing dwindling signs of safety and the then-rising delta variant. But he was rebuffed by several experts, who said there was little data showing whether such widespread use would stop breakthrough infections or curb the overall trajectory of cases.
While the FDA and CDC eventually decriminalized the use of Pfizer boosters, Dr. Biden administration officials, including Anthony Fauci, have suggested additional shots will eventually be recommended for most Americans.
They point to data from Israel showing a low rate of infection and severe illness among people who received a third Pfizer shot.
The FDA meetings come as the US vaccination average has climbed above 1 million per day, a more than 50% increase in the past two weeks. Growth has been primarily driven by the Pfizer booster and employer vaccine mandates.
Read also: COVID-19 vaccine effective against most SARS-CoV-2 variants: Study
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