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CDC approves booster of Moderna and Johnson & Johnson COVID-19 vaccines

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Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), approved booster doses of COVID-19 vaccines for specific groups. Walensky followed the advice of a CDC panel of experts that recommended the boosters in two unanimous votes earlier in the day.

The 15-member Advisory Committee on Immunization Practices (ACIP) recommended that anyone first vaccinated with Moderna vaccination should be given a booster vaccination at least six months later, and that J&J Janssen recipients should receive a booster vaccination at least two months after the initial vaccination. The confirmation follows a similar decision by the Food and Drug Administration (FDA). Both the FDA and CDC also mix or match booster doses so people can get any of the three approved or approved COVID-19 vaccines from Pfizer-BioNTech, Moderna and J&J Janssen as a booster dose. The Moderna booster is half the dose of the original dose.
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“The evidence shows that all three US-approved COVID-19 vaccines are safe – as demonstrated by the over 400 million vaccine doses already administered,” Walensky said in a statement announcing her decision to reduce the risk of serious illness, hospitalization and death, even in the midst of the widespread Delta variant. “

For the time being, the decision only applies to certain groups of people who have been vaccinated against COVID-19. This includes people over the age of 65, as well as people aged 18 to 64 who are at increased risk for severe COVID-19 due to underlying health conditions, or who live or work in a higher risk environment. For example: healthcare workers, grocers, teachers, and those living in long-term care facilities or homeless shelters.

The CDC and FDA previously approved a booster vaccination for Pfizer-BioNTech, and this decision supersedes and includes that approval. As with the previous discussion on booster vaccination, the 15-member committee was relatively unanimous on two things: that because of the lower effectiveness of the J&J Janssen vaccine, people who received this vaccination should receive a booster; and that for people vaccinated with the two mRNA vaccines from Pfizer-BioNTech and Moderna, people over the age of 65 and people with pre-existing conditions should receive a booster dose regardless of their age. However, the panel continued to discuss the need for a booster dose in younger people whose job or living conditions pose a higher risk.

Dr. Sarah Long, Professor of Pediatrics at Drexel University College of Medicine, asked, “What evidence is there that people under the age of 50 should be given a booster at this time?” When the committee discussed this population at the meeting when it chose the Pfizer BioNTech booster, they voted against recommending boosters for those under the age of 50. However, Walensky decided to allow people aged 18 to 64 at high risk of occupational or institutional exposure to have the opportunity to get a booster. This final decision is that these groups can get a refresher instead of receiving it if they so choose.

“The final decision on this is not the right decision,” said Long, referring to today’s final recommendation. “And we’re a bit stuck in it. I can’t say I’m comfortable with someone under 50 – otherwise healthy people – currently in need of a refresher with either Moderna or Pfizer-BioNTech. ”Long noted that the data is not as conclusive as it is for this age group for the elderly or those with underlying health problems, and said the permit implied “smoke and mirrors and sneaky wink and nods”.

However, Long ultimately voted for a refresher after members discussed the need to include specific reminders for physicians in the accompanying fact sheets and clinical guidelines that are being distributed. Specifically, this information suggests that the need for a booster vaccination, especially in younger people, should be carefully weighed against rare but known side effects, including, in the case of the mRNA vaccines, inflammation of the heart tissue, blood clots and guillain. include -Barré syndrome in the admission of J & J-Janssen.

Data presented by the vaccine manufacturers and evaluated by the FDA and CDC showed that the mRNA vaccines continue to offer good protection against severe COVID-19 disease, although their ability to protect people from infection is diminishing. So the unanimous decisions reflected the fact that committee members accepted that approval would mean that some people who would receive the booster may not really need it from a purely immunological point of view, but from a public health point of view, by having the Authorizing booster vaccinations to ensure people can protect themselves against the ongoing pandemic in any way possible is a priority.

With the recommendation, it is now up to vendors – pharmacists, doctors, community workers, and school nurses – to figure out how to introduce booster doses. After the Pfizer BioNTech booster was approved, Walensky found that most vaccinators will rely on people to confirm for themselves that they belong to one of the eligible groups and that they don’t need any documents or other evidence of illness or age.

Giving the boosters will be complicated since Moderna’s booster is half a dose, and both patients and doctors will likely try to play the one study that evaluated what is known as mixing and matching boosters to find out which one is offers the greatest protection. Panel members heard from the co-leader of this study, conducted by the National Institute of Allergy and Infectious Diseases, who stressed that the study was not designed to compare different combinations, but rather to show that mixing Boosters are both safe and effective. Still, these data, which included more than 450 people, suggested that those originally vaccinated with a single dose of J&J Janssen’s vaccine had the greatest protection in the form of anti-virus antibodies when given a Moderna booster. Panelists also discussed the fact that given the risk of clotting events, particularly in younger women vaccinated with J&J Janssen, providers might consider bolstering this population with an mRNA vaccine.

To make matters worse, the FDA and CDC released a third dose of the mRNA vaccines for August People with weakened immune systemsincluding cancer patients, those who have had an organ transplant, or are taking drugs that suppress their immune system. These doses are not used as booster doses, but as an additional dose to strengthen your immune system as part of your initial vaccination against COVID-19. The committee discussed that after the current booster approval, these patients would also be eligible for booster syringes in due course, which would mean a fourth dose for people who were originally vaccinated with an mRNA syringe and a third dose for those who received J&J -Janssen received.

Dr. Grace Lee, chair of the ACIP committee, said it was up to vendors to educate themselves and the public about the complicated booster recommendations and make sure those who really need them get them and benefit from the improved protection. “Our recommendation is only one step along the way,” she said. “For us, it is important to ensure in our implementation that the patients are really informed about the risk-benefit ratio based on their personal situation. It’s the hardest part for us, but I encourage all of us to go beyond these recommendations and do our best to educate our communities and provider teams and work with the public health. “

The fact that mixing doses appears to be both safe and effective could also help support the US government’s booster campaign. Smaller doctor’s offices or community clinics or mobile units that go to long-term care facilities, for example, don’t need to store all three vaccines, but could instead focus on one and streamline the logistics of their vaccination efforts. The White House has said it has bought the necessary supply of booster jars and is ready to ship them now that the FDA and CDC approve them.

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