According to federal decisions, millions of Americans will be allowed to receive a third dose of vaccine against Covid. The decision was made by the Federal Department on Thursday night and Friday.The Food and Drug Administration and Advisory Committee on Immunization practices, an advisory group to the Centers for Disease Control and Prevention let the US catch up with research that showed transplant recipients and patients with cancer are not fully protected by two shots. They also gave approval to unapproved doses to patients already receiving them. It effectively changes the approved vaccine series for people who have weak immune systems to three doses, with the third dose being delivered 28 days after the first.It is not a blanket change. It only covers people who have moderate to severe immune impairment, as defined by the FDA and ACIP. No vaccines for children or preteens have been approved. It does not approve additional shots for immune-impaired individuals who have received the single-dose Johnson & Johnson vaccine. There is no data yet to predict their reactions.The FDA and the committee made sure not to call the third doses boosters. This was to make a distinction between increasing initial protection for people with low immunity and renewing immunity for the rest of society in case vaccine effectiveness decreases. However, this move is still controversial globally. The World Health Organization asked rich countries to stop giving extra shots until the poor can get more.Since a long time, the decision to include a dose for immunocompromised patients was in the making. ACIP is a group that includes medical researchers and representatives from professional societies. It examined evidence last month for the decision. CDC director Rochelle Walensky announced its imminent arrival at a White House Covid-19 Response Team briefing. She stated that this action was to ensure our most vulnerable, who may require an extra dose to boost their biological reactions to the vaccines, are better protected against Covid-19.Late Thursday night, the FDA amended its guidance regarding vaccines. It modified the emergency authorizations for Moderna and Pfizer formulas to include the three dose series. This set the stage for the committee which had already scheduled a Friday morning discussion. The meeting concluded in unanimous support for third doses.The immediate trigger for this change, along with the rise in extra-contagious Delta variants that are sweeping the US, was the publication of studies from Canada as well as France in The New England Journal of Medicine on Wednesday and Thursday. The federal agencies were informed of the findings. Both studies showed that transplant recipients who received two doses of vaccine had very low levels of antibodies. However, they were able to achieve significant immunity protection with a third dose.Atul Humar, a doctor and director of transplantation at University of Toronto, and the senior author of the Canadian trial, stated that these results were definitive and that they are a slam dunk. He spoke on Thursday, before the FDA and CDC acted. The study involved 120 patients undergoing organ transplants. It showed that third-dose recipients had higher T-cell responses than those who received placebo. He said that the results were convincing enough to recommend a third dose for these patients.
