FDA approved Moderna Covid vaccine for emergency use

The Food and Drug Administration has approved the Moderna coronavirus vaccine for emergency use. The vaccine – the second one approved for use in the U.S. behind Pfizer and BioNTech’s – strengthens the U.S. dose supply. The potentially life – saving sights are desperately needed to overcome the pandemic that has taken over 300,000 American lives and transmitted hospitals.

The FDA’s emergency use authority on Friday approved the federal government’s plan to distribute approximately 5.9 million doses of Moderna vaccine to 64 states, districts and major cities nationwide next week.

“We’re likely to see sightings in the arm too early next week, I’d hopefully Monday or Tuesday,” Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, told the “Today” show on Friday morning.

President Donald Trump said in a tweet: “Congratulations, the Moderna vaccine is now available!”

In addition to the Moderna vaccine, the U.S. also plans to release 2 million doses of the Pfizer vaccine after 2.9 million doses were cleared for disposal this week, Gen. Gustave Perna, who will be in charge of logistics for the Operation Warp Speed ​​vaccine project, Monday. Both vaccines require two doses three to four weeks apart. The Moderna Covid vaccine is its first ever FDA-authorized product.

“With two vaccines now available to prevent COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing large numbers of hospitalizations. and daily deaths in the United States, “FDA Commissioner Dr. Stephen Hahn said in a statement.

U.S. officials hope to vaccinate at least 20 million Americans – mostly health care workers and nursing home residents – by the end of the year. Initial doses will be limited as manufacturing ramps up, with officials predicting that it will take months for everyone in the U.S. who wants to get the vaccine. The Centers for Disease Control and Prevention has produced a picture for states that recommends prioritizing health workers and nursing homes, but states can roll out the vaccine as they see fit.

Already, states are reporting upheaval about vaccine plans. In the last few days, state officials said they learned that the second shipment of Pfizer vaccine would be less than expected or delayed. In Florida, for example, Republican Gov. Ron DeSantis had been told by the federal government that the state would receive 205,000 Pfizer vaccine doses next week and 247,000 next week. These loads are now being held, DeSantis said at a press conference Tuesday, and it is unclear when they will arrive.

Moderna vaccines, like Pfizer’s, use messenger RNA technology, or mRNA. It is a new method of vaccines that uses a genetic material to stimulate an immune response. Late-stage clinical trial data published last month show that the Moderna vaccine is more than 94% effective in preventing Covid, is safe and appears to be he gets a bad disease. To achieve maximum effectiveness, the vaccine must be given two doses four weeks apart.

The FDA has stated that it would authorize a Covid-19 vaccine that is safe and at least 50% effective. The flu vaccine, by contrast, typically reduces the risk of people getting flu by 40% to 60% compared to people who are not vaccinated, according to the CDC.

The vaccine authorized the Moderna vaccine for people 18 years of age and older. Such permission from the organization is not the same as full consent, which requires more data and usually takes several months longer. Moderna has only submitted two months of continuous safety data. The agency usually requires six months for full license and can revoke EUA for a drug if it does not work as expected or is dangerous. The FDA approved emergency use of hydroxychloroquine to treat Covid-19 in March, just to be revoked in June after additional data showed it provided “no evidence of benefit” in coronavirus patients.

The FDA’s announcement comes after a major body advisory panel on Thursday voted 20-0 by one voter to recommend the vaccine for emergency use. The Advisory Committee of Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the U.S., ensuring that the sights are safe for public use. While the FDA does not have to follow the advisory committee’s recommendation, it often does.

Prior to the vote, some committee members stressed their lack of support for the Moderna vaccine for full FDA approval, reiterating that the agency needs to review more data on safety and efficacy.

At the meeting, medical experts outside the group asked about reported allergic reactions in two Alaskan health care workers who took the Pfizer vaccine. Doran Fink, deputy director of the FDA’s division of vaccines and related product claims, said the agency is looking into the matter.

“As we continue to analyze and evaluate the data, we will consider whether additional recommendations are needed,” he said. “At this stage, we do not have enough data to make a definitive one-way recommendation or the other way around. “

Fatigue, headaches, and muscle pain are the most common side effects of the Moderna vaccine, along with some rare symptoms such as nausea or vomiting and facial swelling that are likely to be triggered by the symptoms, according to the FDA. Some side effects were difficult to shake off, although most were resolved within a week, the FDA said.

The FDA said that while it is not always a side effect, it recommends that people receiving Pfizer or Moderna vaccine shots be monitored for possible cases of Bell’s palsy, a condition that causes frostbite. sudden or weakness in facial muscles. The group also noted a higher incidence of lymphadenopathy, a disease that can result in swollen or enlarged lymph nodes, in Pfizer and Moderna trials in the vaccine group compared to the placebo groups.

Moderna has said its vaccine remains stable at 36 to 46 degrees Fahrenheit, a normal home temperature or a medical refrigerant, for up to 30 days. It can be stored for up to six months at a rate of 4 degrees Fahrenheit. In contrast, the Pfizer vaccine requires a storage temperature of less than 94 degrees Fahrenheit.

The federal government announced last week that it would purchase an additional 100 million doses of the Moderna vaccine. The U.S. entered into an agreement with Moderna in August to receive 100 million doses for approximately $ 1.5 billion. Moderna said that month it was raising $ 32 to $ 37 per dose for the vaccine for some customers, below “spread prices.” The company said it is negotiating larger size agreements. more at a lower price.

– Noah Higgins-Dunn and Will Feuer from CNBC contributed to this report.