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New York Cite this as: BMJ 2020;371:m4924 Covid-19: FDA authorizes Moderna vaccine as US starts vaccinating http://dx.doi.org/10.1136/bmj.m4924 health workers Published: 21 December 2020 Janice Hopkins Tanne The US Food and Drug Administration (FDA) President Donald Trump has neither received the authorized the Moderna vaccine against covid-19 for vaccine nor made a statement about vaccine emergency use on 18 December, with the US on track distribution. to receive 20 million doses by the end of this month Side effects and a further 85-100 million doses in the first three months of 2021.1 Both Moderna’s and Pfizer-BioNTech’s vaccines use the new messenger RNA (mRNA) technology, but The move follows the authorization of the Moderna’s vaccine can be kept cold in an ordinary Pfizer-BioNTech vaccine for emergency use a week freezer, whereas the Pfizer-BioNTech vaccine must ago. Both vaccines are said to have around 95% be kept at –70°C. efficacy. Pfizer and Moderna have said that they will apply to the FDA for full licensure. Vaccines from Both vaccines require two injections: 21 days apart other makers are expected in early 2021. for the Pfizer vaccine and 28 days apart for the Moderna vaccine. Side effects have been reported Infections and deaths increase in the US every day. with both: pain at the injection site, muscle aches As of 20 December it recorded 193 947 new cases, 2628 and pains, and sometimes a slight fever. new deaths, and 113 929 people hospitalized. The past week has seen an average of 216 705 new cases a day. A few anaphylactic reactions have been reported with The US has so far had 17.8 million cases, by far the the Pfizer-BioNTech vaccine in the UK and the US. highest number in the world.2 Hospitals in several The UK now advises that people with any history of states have said that they are running out of intensive anaphylactic reactions should not receive the vaccine. care unit beds. The CDC says that people who have had an allergic reaction to an ingredient in the vaccines should not Gustave Perna, head of the US government’s receive the vaccine, while people who have not had Operation Warp Speed, which is in charge of allergic reactions to injectable vaccines but have had distributing the vaccines, apologized for some states allergic reactions to food, pets, or medicines—but not

receiving smaller doses of the Pfizer vaccine than http://www.bmj.com/ anaphylactic reactions—may receive it. expected, blaming manufacturing problems.3 Other reports said that the Pfizer vials had more doses than All who receive the vaccine should be monitored for expected and thus were capable of immunizing more 15 to 30 minutes after injection.7 people.4 Correction: On 22 December 2020 we corrected the headline to “FDA Building confidence authorizes Moderna vaccine” (not “approves”). Two vaccines will now be available to many of the 21 million frontline healthcare workers in the US. Next 1 Grady D, Goodnough A, Weiland N. Moderna vaccine is second to get on 25 September 2021 by guest. Protected copyright. cleared by FDA. New York Times 2020 Dec 19. https://www.ny- in line will be staff and residents at age care homes. times.com/live/2020/12/18/world/covid-19-coronavirus. A Centers for Disease Control and Prevention (CDC) 2 Coronavirus in the US: latest map and case count. New York Times 2020 panel voted on 20 December that next in line should Dec 20. https://www.nytimes.com/interactive/2020/us/covid-cases-deaths- be “frontline essential workers” and people over 75.5 tracker.html. 3 Weise E. States were left scrambling after finding out they’d get 20-40% The first person to receive the vaccine was Sandra less vaccine than promised. We now know why. USA Today 2020 Dec 19. Lindsay, director of critical care nursing at Long https://www.usatoday.com/story/news/2020/12/19/federal-vaccine-distri- Island Jewish Health Center in New York City, an area bution-discrepancy-states-less-doses/3960344001/. hard hit at the beginning of the pandemic in the US. 4 Owermohle S. FDA says Pfizer vaccine vials hold extra doses, expanding supply. Politico.com 2020 Dec 17. https://www.politi- Lindsay, who is Black, received the injection from co.com/news/2020/12/16/pfizer-vaccine-extra-doses-447117. Michelle Chester, a Black physician at the hospital. 5 Feuer W. CDC panel says frontline essential workers, people 75 years and This photo-op was an attempt to build confidence for old should get covid vaccine next. CNBC.com 2020 Dec 20. the vaccines in the Black community, where there is https://www.cnbc.com/2020/12/20/cdc-panel-says-frontline-essential- workers-people-75-years-and-older-should-get-covid-vaccine-next.html. much distrust of the medical establishment.6 6 Otterman S. “I trust science,” says nurse who is first to get vaccine in US. Senior US government officials have already received New York Times 2020 Dec 14. https://www.nytimes.com/2020/12/14/nyre- the first dose of the Pfizer vaccine: Nancy Pelosi, gion/us-covid-vaccine-first-sandra-lindsay.html. 7 Centers for Disease Control and Prevention. Covid-19 vaccines and severe speaker of the House; Mitch McConnell, Senate allergic reactions. Updated 19 Dec 2020. https://www.cdc.gov/coron- majority leader; Vice President Mike Pence and his avirus/2019-ncov/vaccines/safety/allergic-reaction.html. wife, Karen Pence; and the US surgeon general, Jerome Adams. President elect Joe Biden and his wife, This article is made freely available for use in accordance with BMJ's website Jill Biden, will receive injections on 21 December. terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained. the bmj | BMJ 2020;371:m4924 | doi: 10.1136/bmj.m4924 1