FDA panel endorses booster doses of Johnson & Johnson’s single-shot COVID-19 vaccine

A panel of the US Food and Drug Administration advocated booster vaccination of Johnson & Johnson’s one-time COVID-19 vaccine for people 18 years and older on Friday.

J&J has asked the FDA for flexibility, arguing that the extra dose provides important protection as early as two months after the primary vaccination – but that it might work better if people wait until six months later, the Associated Press reported.

The FDA panel unanimously agreed that a booster should be offered without a fixed date. The panel cited concerns that those who received the J&J vaccine appear to be less protected than people who received the two-dose Pfizer or Moderna options – and that most received that single dose many months ago reported the AP.

The FDA usually makes a decision on approving the emergency application a few days after the advisory panel’s recommendation. Following this decision, approval from the Centers for Disease Control and Prevention is required before the shots are made available to specific groups.

On Thursday, the federal advisory board recommended a half dose of Moderna’s COVID vaccine as a booster for people aged 65 and over, as well as adults with other health problems, jobs or life situations that put them at increased risk for COVID. The FDA and CDC have already approved Pfizer boosters for similar groups.

“It will be interesting to see if the population has that [the J&J shot] has the same intake of boosters as the other group, “Erin Carlson, director of graduate programs in public health at the University of Texas at Arlington, told The Dallas Morning News. “Some people were very convinced that this was a one-shot [vaccination]. “

The government says all three U.S. vaccines continue to offer strong protection against hospitalization and death from COVID, and that the first shots of the 66 million eligible but unvaccinated Americans who are most at risk are priority, the AP reported . But with the spread of the extra contagious Delta variant and the signs of declining immunity to lighter infections, the nation is moving towards a broader booster campaign.

Looking ahead, the panel is due to discuss Pfizer’s vaccine for children ages 5-11 on October 26th.

On Friday, the panel of independent vaccine experts also looked at the safety and benefits of “mixing and matching” vaccines – for example, taking a Pfizer booster after receiving the Moderna or Johnson & Johnson vaccine.

Preliminary results from an ongoing study of different ways to mix and match different shots showed that a booster of any kind increases people’s antibody levels – at least for a few weeks. And the most dramatic jump came from giving a Pfizer or Moderna syringe after the single-dose J&J vaccination, the AP reported.

FDA advisors did not vote on whether this should be recommended, but urged the government to allow flexibility in boosters-deadline protection, the AP reported.

Dr. Angelica Cifuentes Kottkamp, ​​assistant professor of medicine at NYU Langone Health in New York, told The News that with these results, doctors and researchers can say with confidence that these boosters are safe and effective in producing an immune response regardless of vaccine regimen .

Mixing and matching vaccines can also boost declining immunity and widen the breadth of immunity to variants, she said.

The National Institutes of Health is conducting a clinical study to evaluate both the safety and effectiveness of using a COVID vaccine booster that is different from the starting dose. As the NIH clinical trial continues, researchers are studying immune responses for several variants, Kottkamp told The News.

“Mixing vaccines safely should allow other nations to prioritize products and meet vaccination goals,” said Kottkamp. “However, for a better answer, and to be completely on an equal footing, we should try to test combinations that contain other vaccines used around the world, not just those approved in the US [U.S.]”

Meanwhile, Oxford University researchers are studying the effects of mixing and matching the doses of the Pfizer and AstraZeneca vaccines, the New York Times reported.

Preliminary results show the Pfizer-AstraZeneca combination was well tolerated, Kottkamp told The News.

From a “vaccine distribution and equity perspective, the ideal would be if you could just give the Pfizer vaccine.” [booster] for everyone, no matter what their original series was. But we don’t really have the data to back it up right now, ”Ed Belongia, epidemiologist and vaccine researcher at the Marshfield Clinic Research Institute in Wisconsin, told The News in September.

J&J said his studies showed that people who received an injection two months after the first had their antibody levels increased four to six times. A booster dose six months after the first dose resulted in a 12-fold increase.

This interval between the doses – two months and six months – interests the researchers. The results suggest the possibility that a person’s immune response could be stronger with a longer interval between doses of the COVID vaccine.

“I’m just wondering [about] the two months after the first dose – is it enough or should it be? [longer]? And I’m sure they’ll look into that, ”said Dr. Francesca Torriani, a professor of medicine in the Department of Infectious Diseases at the University of California San Diego, told The News in September.

“[These] The results also suggest months of waiting between doses can provide even more protection, “UT Arlington’s Carlson told The News in September.

The Associated Press contributed to this report.

Many health professionals say mixing and matching COVID-19 vaccine syringes is not recommended until more data is available.  Little is known about how different types of vaccines interact with one another, according to a previous report in the Dallas Morning News.The fast breath testing device developed by the Dallas-based biotech company SOTECH Health in collaboration with researchers from UT Dallas.Dr.  Yomaris Pena, an internal medicine doctor at Somos Community Care, extracts the last piece of Pfizer COVID-19 vaccine from a vial at a vaccination site in the Corsi Houses in East Harlem, New York.  The number of COVID-19 vaccinations is falling in the US.Parkland Hospital pharmacist Henna Choi prepares a Pfizer vaccine during a vaccination clinic hosted by Parkland Hospital in Glenn Heights at the Glenn Heights Senior Center on Saturday, September 11, 2021.  Glenn Heights is only 20% vaccinated, according to the county.

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