The FDA panel recommends emergency approval

An effective advisory committee from the Food and Drug Administration on Thursday overwhelmingly endorsed Modernna’s coronavirus vaccine, paving the way for the delivery of another Covid-19 vaccine in the United States next week.

The non-binding decision adopted by the FDA’s Vaccine and Related Biological Products Advisory Committee, with one to 20, the external group of vaccines and infectious disease experts voted to recommend the Pfizer and BYNTEC vaccines for authorization for emergency use, or. The agency approved Pfizer’s EU the next day and the U.S. The first inoculations were given on Monday.

FDA Advisory Committee, U.S. Plays a major role in approving the flu and other vaccines, to verify that shots are safe for public use. While the FDA does not need to follow the recommendation of an advisory committee, it often does. General Gustave Parna, who oversees logistics for the US Operation Worm Speed ​​Vaccine project, plans to build a ship under just 6 million doses to the United States next week on Monday.

Before voting, some members of the committee insisted that their support for the modern vaccine was not for the FDA’s full approval, reiterating that the agency would still need to review more data on safety and effectiveness.

A voting member of the Tufts University School of Medicine and a contagious disease specialist, Dr. Support is based on “available evidence but is limited.”

The EU means the FDA will allow some people to be vaccinated because the agency keeps evaluating the data. It’s not the same as full approval, which requires more data and usually takes several months longer. Modern has submitted only two months of follow-up safety data. The agency usually needs six months for full approval. The committee has recommended immediate authorization of the vaccine for people 18 years of age or older.

Voting member Dr. James Hildrath was the only member who did not say yes. He said he decided to give up because it was “uncomfortable” to support the vaccine for everyone 18 years of age or older.

“Between the epidemic and the limited vaccine supply, the statement of a blanket for individuals 18 years of age or older is simply too broad,” said Hilderath, president and CEO of Mehri Medical College. The benefits of those age groups actually outweigh the risks. “

Initial dose manufacturing ramps will be limited up, with officials predicting that U.S. It will take months for everyone who wants to be vaccinated to get vaccinated. The Centers for Disease Control and Prevention has provided states with an outline that recommends giving preference to health care workers and nursing homes, but states can distribute the vaccine as they see fit.

Modern vaccine messenger RNA Or mRNA, using technology. It is a new approach to vaccines that uses genetic material to provoke an immune response. Phased clinical trial data show that the vaccine is more than 94% effective in preventing covid, appears to be safe and prevents serious disease. To achieve maximum effectiveness, the vaccine requires two doses every four weeks.

The FDA has indicated that it will protect the Covid-19 vaccine, which is safe and at least 50% effective. According to the CDC, flu vaccines, in general, reduce the risk of influenza by 40% to 60% compared to people who do not inoculate.

FDA staff on Tuesday said in documents supporting the modern vaccine that the results of clinical trials and safety data were “consistent with the recommendations outlined in the FDA’s guidelines on emergency use authorization for vaccination to prevent COVD-19.”

The FDA said 13 people had died by Dec. 3, including six in the vaccine group. The two deaths in the vaccine group were 75-year-olds who had a preexisting condition, the agency said. One case was a 72-year-old vaccinator with Crohn’s disease and short bowel syndrome who was hospitalized for thrombocytopenia and acute kidney failure.

According to the FDA, the most common side effects from the Moderna vaccine are fatigue, headaches and muscle aches, as well as some rare symptoms such as interactive ause or lumbar and facial swelling, according to the FDA. Some side effects were difficult to shake off, although most were resolved within a week, the FDA said.

During a meeting Thursday, medical experts also asked the agency about allergic reactions, which were followed by two cases involving health care workers in Alaska who had received the Pfizer vaccine. Doran Fink, deputy director of the FDA’s Department of Applications for Vaccines and Related Products, said the agency would continue to investigate the case.

“As we continue to examine and evaluate the data, we will consider whether additional recommendations need to be made,” he said. “At the moment, we don’t have enough data to make a definite recommendation in one way or another.”

There is very little data on vaccine safety in pregnant women and children. Thirteen pregnancies were recorded in the Moderna trial by December, including six in the vaccine group, the FDA said. According to the agency, the company is monitoring all women who became pregnant after being vaccinated or who were pregnant when they were vaccinated but did not know, according to the agency.

Dr David Martin, vice president of drug safety at Moderna, told the committee on Thursday that the company would set up a “pregnancy registry” to track how the vaccine works in pregnant women.

“In terms of safety in the event of exposure to the vaccine during pregnancy, a developmental and reproductive study was completed in December 2020, with no adverse results.” Martin told the committee. “Given the limited human exposure to date in the three-phase trial, we will establish a pregnancy registry that includes a group recruited from the general population.”

While side effects may not be necessary, the FDA said it recommends monitoring people who receive Pfizer or Moderna vaccine shots for possible cases of Bell’s paralysis, a condition that causes sudden freezing or weakness of the facial muscles. In Pfizer and Moderna trials in the vaccine group compared to the placebo groups, the agency also noted a widespread prevalence of lymphadenopathy, which can cause a swollen or enlarged lymph node.

Moderna said its vaccine stays stable at 36 to 36 to 46 degrees Fahrenheit, which is the standard home or medical refrigerator temperature, up to 30 days. It can be stored for up to six months at a negative 4 degrees Fahrenheit. By comparison, a Pfizer vaccine requires a storage temperature of minus 94 degrees Fahrenheit.

The federal government announced last week that it would purchase an additional 100 million doses of the modern vaccine. The U.S. signed a deal with Moderna in August to receive 100 million doses for about 1.5 1.5 billion. Moderna said cheaper “epidemic prices” that month. Under some consumers charged 32 to 37 dollars for the dose for its vaccine. The company said it is in talks for a larger volume deal that will cost less.

CNBC Noah Higgins-Dunn Contributed to this article.