FDA panel recommends emergency approval

An influential Food and Drug Administration advisory panel on Thursday endorsed the modernism’s coronavirus vaccine, an important step paving the way for the second Kovid-19 vaccine to be distributed in the United States next week.

The non-binding decision, which was adopted with an abstraction from 20 to 0 from the FDA’s Vaccine and Related Biological Products Advisory Committee, came exactly one week after the vaccine’s external group and infectious disease specialists arrived at an emergency use authority. Vote for recommendation of Pfizer and BioNotech vaccines for, or EUA. The agency delivered the EUA of Pfizer the next day and the first vaccination in the US on Monday.

The FDA Advisory Committee plays a key role in approving flu and other vaccines in the US, verifying that the shots are safe for public use. While the FDA does not have to follow the recommendation of the advisory committee, it often is. The US plans to ship just under 6 million doses next week, pending the agency’s OK, General Gustav Perna, who oversees logistics for the Operation War Speed ​​Vaccine project, told reporters on Monday.

The EUA means the FDA will allow some people to receive the vaccine as the agency continues to evaluate the data. This is not the same as full acceptance, which requires more data and can usually take several months. Modern has accumulated only two months of follow-up safety data. The agency typically requires six months for full approval. The committee recommended the Emergency Authority of Vaccines for those 18 and older.

The initial dose will be limited as manufacturing ramps up, with officials predicting that it will take months to vaccinate everyone in the US who wants to be vaccinated. The Centers for Disease Control and Prevention has provided states with a framework that recommends prioritizing health care workers and nursing homes, but can distribute vaccines to states as they see fit.

Modern’s vaccine messenger uses RNA, or mRNA, technology. This is a new approach to vaccines that uses genetic material to provoke an immune response. Late stage clinical trial data suggest that the vaccine is more than 94% effective in preventing kovid, is safe and appears to cause serious illness. To achieve maximum effectiveness, the vaccine needs to be taken two doses four weeks apart.

The FDA has indicated that it will authorize a Kovid-19 vaccine that is safe and at least 50% effective. The flu vaccine, according to the CDC, typically reduces the risk of influenza by 40% to 60% compared to those who are not vaccinated.

FDA staff on Tuesday endorsed Modern’s vaccine, saying in the documents that clinical trial results and safety data “were consistent with the recommendations outlined in the FDA’s Guidance on the Emergency Use Authority for Vaccines to Prevent COVID-19” . “

The FDA said the vaccine group reported 13 deaths with six. The agency said that two deaths in the vaccine group were over 75 people. One case was a 72-year-old vaccine recipient with Crohn’s disease and short bowel syndrome hospitalized for thrombocytopenia and acute renal failure.

According to the FDA, fatigue, headaches and muscle aches are the most common side effects from modern-day vaccines, with some rare symptoms likely to be triggered by shots such as nausea or vomiting and swelling of the face. The FDA stated that some side effects were difficult to shake off, although that was resolved within a week.

During Thursday’s meeting, medical experts also asked the agency about allergic reactions, with two cases reported among Alaskan health care workers who took Pfizer’s vaccine. Doran Fink, the FDA’s division of vaccines and deputy director of applications for related products, said the agency would continue to investigate the cases.

“As we continue to examine and evaluate the data, we will consider whether additional recommendations need to be made,” he said. “At this point, we do not have enough data to recommend one way or the other in the definitive way.”

There are very few statistics regarding the safety of the vaccine in pregnant women and children. The FDA has stated that Thirteen pregnancies were reported in Modern’s trial with six in the vaccine group. The company is tracking all women who became pregnant after receiving the vaccine or who were pregnant when they were vaccinated but according to the agency they were not aware.

Dr. Vice President of Drug Safety at Modern. David Martin told the committee on Thursday that the company would set up a “pregnancy registry” to track how its vaccine is administered to pregnant women.

Martin told the committee, “Regarding the safety of exposure to vaccines during pregnancy, a developmental and reproductive study was not completed in December 2020.” “Given the limited human exposure to date in phase three trials, we will establish a pregnancy registry that includes a cohort recruited from the general population.”

While not necessarily a side effect, the FDA said it recommends monitoring people who receive Pfizer or Modern’s vaccine shots for possible cases of Bell’s paralysis, a condition that causes a sudden cold in the facial muscles Or causes weakness. The agency also noted a higher prevalence of lymphadenopathy, a disease that can produce inflamed or enlarged lymph nodes in Pfizer and Modern’s trials in the vaccine group compared to the placebo groups.

Modern has said that its vaccine remains stable at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medical refrigerator, for up to 30 days. It can be stored for up to six months at a negative 4 degrees Fahrenheit. By comparison, Pfizer vaccines require a storage temperature of minus 94 degrees Fahrenheit.

The federal government announced last week that it would buy an additional 100 million doses of Modern’s vaccine. The US entered into an agreement with Modern to acquire 100 million doses for about $ 1.5 billion in August. Modern said that month it was charging $ 32 to $ 37 per dose for vaccines for some customers under cheaper “epidemic pricing”. The company said it was in discussion for large-volume agreements that would cost less.

Noah Higgins-Dunn of CNBC contributed to this article.

This is a developing story. Please check back for updates.


Leave a Reply

Your email address will not be published.