Washington-Johnson & Johnson will ask federal regulators to approve booster shots of the coronavirus vaccine earlier this week, according to officials familiar with the company’s plans. The company is the last of three federal-licensed vaccine providers to require additional injections, at least with increasing evidence that older people and other high-risk groups need more protection.
Federal officials have become increasingly worried that more than 15 million Americans vaccinated with Johnson & Johnson are facing too much of a serious Covid-19 risk. The Food and Drug Administration on Friday scheduled a meeting on October 15 of its Expert Advisory Board to discuss whether to grant an emergency use authorization for Johnson & Johnson’s vaccine booster shots.
This is part of a wide range of government efforts to enhance the protection provided by all three vaccines. Regulators approved booster shots for many Pfizer-BioNTech vaccine recipients last month and are considering doing the same for Moderna vaccine recipients this month.
The fact that the Johnson & Johnson Advisory Board was scheduled before applying to the Food and Drug Administration reflects the Biden administration’s special sense of urgency to provide more protection to its vaccine recipients. increase.
The federal government has emphasized for months that all three vaccines are highly effective, but a recent study by the US Centers for Disease Control and Prevention found that Johnson & Johnson’s single-dose vaccines came from Covid-19. It was found that only 71% was effective for hospitalization. 88% of Pfizer-BioNTech vaccines and 93% of Moderna vaccines.
“Actual data suggest that a double-dose Moderna and Pfizer-BioNTech mRNA vaccine regimen provides more protection than a single-dose Johnson & Johnson dose,” the researchers said. Other studies have found that Johnson & Johnson recipients are more likely to be infected with breakthrough or symptomatic Covid-19 than recipients of the other two vaccines. ..
Johnson & Johnson cites some studies that have yielded better results. A study of about 2 million people funded by the company estimated that the vaccine was 81% effective against hospitalization. According to other studies, protection from the Johnson & Johnson vaccine does not diminish over time like protection from the Pfizer-BioNTech vaccine.
Nevertheless, Johnson & Johnson now seems to agree with federal authorities that a single shot of the vaccine is not enough.
Last month, the company announced that a second dose, two months after the first dose, increased the effectiveness of the vaccine against symptomatic Covid-19 by about 22 points to 94%. The company also said that the two injections were 100% effective for serious illness, but the estimates were not conclusive.
“Data show that when boosts are given in two months, efficacy increases dramatically. Dan, a virologist at the Beth Israel Deaconess Medical Center in Boston, helped develop the vaccine. Dr. H. Barouch said:
“I’m not a public health authority, but it’s scientifically reasonable for people who want a higher level of efficacy to get a booster shot between the first injection of the vaccine and two to six months. I think, “he said.
At a meeting of the CDC Advisory Board in September, some independent experts forgot Johnson & Johnson recipients when the federal government moved to approve the third shot of Pfizer recipients. I asked if it was done.
“For me, the biggest policy issue there is Johnson & Johnson,” Dr. Helen Cape Talbot, a physician and infectious disease expert at Vanderbilt University, said at a meeting last month. Considered whether to recommend a third shot. For some Pfizer recipients. “I’m worried that something bigger and more important in a pandemic might distract me from the Pfizer booster issue.”
Dr. Nilav D. Shah, Chief Health Officer in Maine and Chairman of the Association of State and Community Health Officials, said the Johnson & Johnson vaccine would only require a single injection after it became available this spring. , Said that many states directed vaccines to rural areas. It was easy to transport.
“Currently, the rural areas are particularly hit,” said Dr. Shah. “Therefore, if the data supports it, I think there is a good reason to provide boosters to J. & J. Recipients.”
In San Francisco last month, health officials said Johnson & Johnson recipients would be allowed to receive booster shots of either the Moderna or Pfizer vaccine. “If people talk to their health care providers and say,’I really want a shot of mRNA in addition to the Johnson & Johnson shot I got,’ we’ll do that,” said the city’s public. One Health Director, Dr. Grant Corfax, told reporters.
Important questions remain for federal regulators and the government’s external expert committee. How long do I need to give a second injection after the first Johnson & Johnson injection? And is it better to boost Johnson & Johnson recipients with shots of Moderna or Pfizer vaccines?
If the Food and Drug Administration approves the second shot six months after the first injection, the company can sell the vaccine as a one-shot regimen and booster. Some data show that the 6-month second shot showed a stronger immune response than the 2-month second shot.
Researchers found that antibodies were 9 among the recipients of clinical trials who received the second injection 6 months later, compared to a 4-fold increase in those who received the second dose 2 months later. Dr. Barouch said he found an increase of ~ 12 times.
However, there may be trade-offs. Some Johnson & Johnson recipients claim that the extra months before the second shot are not well protected and that the double-dose regimen makes more sense from the beginning.
Timing is not a simple question. According to CDC data, more than two-thirds of Johnson & Johnson recipients were vaccinated at least four months ago. Many are not immediately eligible if booster shots were available only 6 months after the first injection.
Vaccine Obligation Status in the United States
- Vaccine rules.. On August 23, the FDA granted full approval of the Pfizer-BioNTech coronavirus vaccine for people over the age of 16 paving the way for mandatory both public and private sectors. rice field. Such obligations are legally permitted and are upheld in court opposition.
- University. More than 400 universities require students to be vaccinated with Covid-19. Almost all are in the states that voted for President Biden.
- school. California is the first state to issue a vaccine obligation to all educators and has announced plans to add the Covid-19 vaccine as a requirement to attend school as early as next fall. In Los Angeles, public school students over the age of 12 who will be attending classes directly from November 21st are already obliged to vaccinate. Vaccine obligations have been introduced for teachers and staff in New York City, but due to legal issues, they have not yet come into effect. On September 27, the Federal Court of Appeals overturned the decision to suspend its mission.
- Hospitals and medical centers.. Many hospitals and major healthcare systems require employees to be vaccinated. Obligations to healthcare professionals in California and New York seem to have forced thousands of holdouts to receive shots.
- New York City.. Indoor dining, gyms, performances and other indoor situations require vaccination certification for workers and customers. City education staff and hospital workers also need to be vaccinated.
- At the federal level. September 9 President Biden …