As the country struggles to cope with the wave of Covid-19 infections driven by highly contagious delta variants, the FDA now allows booster vaccines-but only for organ transplant patients and other patients whose immune systems are weakened due to health conditions. FDA has Expand emergency authorization The messenger RNA vaccine includes this narrow patient population.
The regulatory actions announced on Thursday night only covered the booster injection of mRNA vaccines from Moderna and its partners Pfizer and BioNTech. The status of the third FDA-authorized Covid vaccine from Johnson & Johnson remains unchanged. The update comes before the scheduled Friday meeting of the Centers for Disease Control and Prevention’s Immunization Practice Advisory Committee, which will discuss clinical recommendations for vaccination of people with weakened immune systems.
FDA Acting Commissioner Janet Woodcock said in the announcement that the agency has renewed its emergency authorization because it is more difficult for people with weakened immune systems to fight infections, which puts them at a particularly high risk of serious diseases. These patients can benefit from the additional protection provided by the third needle. She added that those who are fully vaccinated with the authorized Covid vaccine are fully protected and do not need booster vaccination. That might change.
“The FDA is actively participating in a rigorous science-based process with our federal partners to consider whether additional doses may be needed in the future,” Woodcock said.
The two licensed mRNA vaccines are administered in two injections. Pfizer’s injections are three weeks apart; Moderna’s shots are four weeks apart. According to the updated authorization, the booster of the two vaccines should be administered at least 28 days after the patient receives the second dose of the conventional double-dose vaccination regimen.
inside Update authorization informationThe US Food and Drug Administration said it reviewed the safety and efficacy data of two manuscripts on solid organ transplant recipients. The first study was conducted in 101 patients who had previously received organ transplants. These patients had received heart, kidney, liver, lung, and pancreas transplants. Among them, 99 patients received the third dose of Pfizer/BioNTech vaccine approximately two months after receiving the second injection of the two-dose regimen.
Among 59 patients who tested negative for the virus, 26 (44%) showed that the level of total SARS-CoV-2 binding antibodies appeared 4 weeks after the third dose of vaccine. In the entire group, 67 (68%) of 99 patients who received the third injection were later considered to have “significantly significant” antibody levels.
The results showed that the side effects of the third injection were similar to those observed after the second injection. No serious adverse events were reported.
For the Moderna vaccine, the FDA reviewed the results of a study in which 60 patients received the third injection approximately two months after the second vaccination. The study compared these patients with 60 people who took a placebo with saline. The main goal is to measure the level of antibodies to the receptor binding domain of the novel coronavirus.
This The results show that Four weeks later, of the 60 patients who were given the third dose of Moderna, 33 (55%) had a significant level of SARS-CoV-2 binding antibodies.” Subjects who took the placebo for the third time Among the 57 study participants, 10 (17.5%) showed this reaction. Like the third shot of Pfizer/BioNTech, the side effects of Moderna booster are similar to those of the second dose of vaccine, and no serious adverse events have been reported.
The Pfizer-BioNTech Covid vaccine license covers people 12 years and older. Moderna vaccine is authorized for people 18 years and older; in June, a biotech company based in Cambridge, Massachusetts Make a request Expand the mandate to include young people.
Photo courtesy of FDA
