The Food and Drug Administration has approved Moderna’s coronavirus vaccine for emergency use. The vaccine – the second approved for use in the US behind Pfizer and BioNTech’s – supports the dose offering in the US. The potentially life-saving shots are badly needed to ward off the pandemic that claimed more than 300,000 American lives and overwhelmed hospitals.
The FDA’s emergency use clearance on Friday approves the federal government’s plan to distribute approximately 5.9 million doses of Moderna vaccine across 64 states, territories and major cities in the country next week.
“We will probably see shots in the arm early next week, I hope Monday or Tuesday,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, on the “Today” show on Friday morning.
President Donald Trump said in a tweet, “Congratulations, the Moderna vaccine is now available!”
In addition to Moderna’s vaccine, the US also plans to send 2 million doses of Pfizer’s vaccine after 2.9 million doses were released for shipment this week, said General Gustave Perna, who oversees logistics for the Operation Warp Speed vaccination project. , Monday. Both vaccines require two doses three to four weeks apart. Moderna’s Covid vaccine is the very first FDA-approved product.
“With the availability of two vaccines for the prevention of COVID-19, the FDA has taken another critical step in the fight against this global pandemic that is causing massive numbers of hospitalizations and deaths every day in the United States,” said FDA Commissioner Dr. Stephen Hahn said in a statement.
US officials hope to vaccinate at least 20 million Americans – mostly primary care health workers and nursing home residents – by the end of the year. Initial doses will be limited as production increases, with officials predicting it will take months to immunize anyone in the US who wants to be vaccinated. The Centers for Disease Control and Prevention has provided states with an overview recommending that health workers and nursing homes be prioritized, but states can distribute the vaccine at their discretion.
States are already reporting confusion about vaccination plans. In recent days, state officials said they heard their second shipment of the Pfizers vaccine would be smaller than expected or delayed. In Florida, for example, Republican Gov. Ron DeSantis said the federal government told him the state would receive 205,000 Pfizer vaccine doses next week and 247,000 the following week. Those shipments are now on hold, DeSantis said at a news conference on Tuesday, and it is unclear when they will arrive.
Moderna’s vaccine, like that from Pfizer, uses messenger RNA or mRNA technology. It is a new approach to vaccines that uses genetic material to elicit an immune response. Data from late-stage clinical studies published last month show that Moderna’s vaccine is more than 94% effective in preventing Covid, is safe and appears to ward off serious illness. To achieve maximum effectiveness, the vaccine requires two doses four weeks apart.
The FDA has indicated it would approve a Covid-19 vaccine that is safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people’s risk of getting the flu by 40% to 60% compared to people who have not been vaccinated, according to the CDC.
The FDA has approved Moderna’s vaccine for people 18 and older. Such authorization from the agency is not the same as full approval, which requires more data and can usually take several months longer. Moderna has only submitted two months of follow-up safety data. The agency usually takes six months for full approval and can always revoke an EUA for a drug if it doesn’t work as intended or turns out to be unsafe. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March, to withdraw it in June after additional data showed it showed “no evidence of benefit” in coronavirus patients.
The FDA’s announcement comes after a major advisory panel of the agencies voted 20-0 on Thursday with one abstention to recommend the vaccine for emergencies. The Advisory Committee on Vaccines and Related Biological Products plays a key role in approving flu and other vaccines in the US and verifying that the injections are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does.
Ahead of the vote, some members of the committee stressed that their approval of Moderna’s vaccine was not for full FDA approval, reiterating that the agency still needs to review more data on safety and effectiveness.
At the meeting, outside medical experts asked the agency about allergic reactions reported in two Alaskan health workers who were using Pfizer’s vaccine. Doran Fink, deputy director of the FDA division of vaccines and related product applications, said the agency is investigating the matter.
“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 don’t have enough data to somehow make a definitive recommendation.”
Fatigue, headaches, and muscle pain are the most common side effects of Moderna’s vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling likely caused by the shots, according to the FDA. Some of the side effects were difficult to shake, although most resolved within a week, the FDA said.
The FDA said that while it is not necessarily a side effect, it recommends that people who receive Pfizer or Moderna vaccinations for possible cases of Bell’s palsy, a condition that causes sudden frostbite or weakness in the facial muscles. The agency also noted a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the Pfizer and Moderna studies in the vaccine group compared to the placebo groups.
Moderna has said the vaccine will remain stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a standard home or medicine refrigerator. It can be stored at minus 4 degrees Fahrenheit for up to six months. In comparison, Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit.
The federal government announced last week that it will purchase an additional 100 million doses of Moderna vaccine. The US entered into an agreement with Moderna in August to acquire 100 million doses for approximately $ 1.5 billion. Moderna said it charged $ 32 to $ 37 per dose that month for its vaccine for some customers, below cheaper “pandemic prices.” The company said it was in discussion for larger volume deals that will have a lower price.
– The Washington City Times’s Noah Higgins-Dunn and Will Feuer contributed to this report.