FDA approves second emergency Covid vaccine as Moderna is accepted for distribution in the USA
The Food and Drug Administration has approved Moderna's coronavirus vaccine for emergency use. The vaccine – the second to be approved for use in the US after Pfizer and BioNTech – strengthens the US dose supply. The potentially life-saving shots are badly needed to fight the pandemic that left more than 300,000 Americans dead and hospitals overwhelmed.
With the FDA's approval for the emergency on Friday, the federal government's plan to distribute approximately 5.9 million doses of Moderna's vaccine to 64 states, territories and major cities across the country next week will be approved.
"We'll probably see gunshots in the arm early next week, I hope Monday or Tuesday," said Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, on the "Today" show on Friday morning.
In addition to Moderna's vaccine, the U.S. is planning to ship 2 million doses of Pfizer's vaccine after 2.9 million doses were cleared for shipping this week, General Gustave Perna, who oversees logistics for the Operation Warp Speed vaccination project, said Monday . Both vaccines require two doses three to four weeks apart. Moderna's Covid vaccine is the first product to be approved by the FDA.
"With the availability of two vaccines to prevent COVID-19, the FDA has taken another crucial step in the fight against this global pandemic, which causes large numbers of hospitalizations and deaths in the US every day," said FDA Commissioner Dr. Stephen Hahn said in a statement.
US officials hope to vaccinate at least 20 million Americans by the end of the year – mostly healthcare frontline workers and nursing home residents. The initial doses will be limited as production increases. Authorities predict it will be months before everyone in the US who wishes to be vaccinated is vaccinated. The Centers for Disease Control and Prevention has given states an overview recommending prioritizing health workers and nursing homes. However, states may distribute the vaccine at their own discretion.
States are already reporting confusion about vaccination plans. In the past few days, state officials said they learned that their second shipment of Pfizer's vaccine would be smaller than expected or delayed. In Florida, for example, Republican Governor Ron DeSantis said the federal government had 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 press conference Tuesday, and it is unclear when they will arrive.
Moderna's vaccine, like Pfizer's, uses messenger RNA or mRNA technology. It's a new approach to vaccines that uses genetic material to trigger an immune response. Late-stage clinical trial data released last month shows that Moderna Covid's vaccine is more than 94% effective at preventing, safe and appearing to fight off serious diseases. For maximum effectiveness, the vaccine requires two doses four weeks apart.
The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.
The FDA has approved Moderna's vaccine for people aged 18 and over. Such authorization by the agency is not the same as a full authorization, which requires more data and can usually take several months longer. Moderna only submitted security data for two months. The agency typically takes six months for full approval and can revoke an EEA for a drug at any time if it doesn't work as intended or if it proves unsafe. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March but revoked it in June after additional data showed it provided "no evidence of benefit" in coronavirus patients.
The FDA announcement comes after a key agency advisory body voted 20-0 with one abstention on Thursday to recommend the emergency vaccine. The Advisory Committee on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not need to follow the advisory board's recommendation, it often does.
Prior to the vote, some committee members stressed their approval of Moderna's vaccine was not in favor of full FDA approval, and reiterated that the agency needed to review more data on safety and efficacy.
During the meeting, outside medical experts asked the agency about allergic reactions reported in two Alaskan health workers who were taking Pfizer's vaccine. Doran Fink, deputy director of the FDA's vaccines and related product applications division, said the agency is looking into the problem.
"As we continue to examine and evaluate the data, we will consider whether additional recommendations need to be made," he said. "Right now we don't have enough data to make a final recommendation one way or another."
Fatigue, headaches, and muscle aches are the most common side effects of Moderna's vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling, which the FDA says are likely caused by the gunfire. Some side effects were tough to shake, although most were resolved within a week, the FDA said.
The FDA said while this isn't necessarily a side effect, it does recommend monitoring people who receive Pfizer's or Moderna's vaccine shots for possible cases of Bell's palsy, a condition that causes sudden freezing or weakness of facial muscles. The agency also found a higher prevalence of lymphadenopathy, a disease that can cause swollen or enlarged lymph nodes, in the vaccine group compared to the placebo groups in Pfizer and Moderna studies.
According to Moderna, the vaccine will stay stable for up to 30 days at 36 to 46 degrees Fahrenheit, the temperature of a normal household or medical 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 it would buy another 100 million doses of Moderna's vaccine. The US reached an agreement with Moderna in August to purchase 100 million cans for about $ 1.5 billion. Moderna said it charged some customers $ 32 to $ 37 per dose for its vaccine at lower "pandemic prices" this month. The company said it was under discussion for larger volume agreements that will have a lower price.
– CNBC's Noah Higgins-Dunn and Will Feuer contributed to this report.