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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
Published: 21 December 2020
health workers
Janice Hopkins Tanne
The US Food and Drug Administration (FDA)
authorized the Moderna vaccine against covid-19 for
emergency use on 18 December, with the US on track
to receive 20 million doses by the end of this month
and a further 85-100 million doses in the first three
months of 2021.1
The move follows the authorization of the
Pfizer-BioNTech vaccine for emergency use a week
ago. Both vaccines are said to have around 95%
efficacy. Pfizer and Moderna have said that they will
apply to the FDA for full licensure. Vaccines from
other makers are expected in early 2021.
Infections and deaths increase in the US every day.
As of 20 December it recorded 193 947 new cases, 2628
new deaths, and 113 929 people hospitalized. The past
week has seen an average of 216 705 new cases a day.
The US has so far had 17.8 million cases, by far the
highest number in the world.2 Hospitals in several
states have said that they are running out of intensive
care unit beds.
Gustave Perna, head of the US government’s
Operation Warp Speed, which is in charge of
distributing the vaccines, apologized for some states
receiving smaller doses of the Pfizer vaccine than
expected, blaming manufacturing problems.3 Other
reports said that the Pfizer vials had more doses than
expected and thus were capable of immunizing more
people.4
Building confidence
Two vaccines will now be available to many of the 21
million frontline healthcare workers in the US. Next
in line will be staff and residents at age care homes.
A Centers for Disease Control and Prevention (CDC)
panel voted on 20 December that next in line should
be “frontline essential workers” and people over 75.5
The first person to receive the vaccine was Sandra
Lindsay, director of critical care nursing at Long
Island Jewish Health Center in New York City, an area
hard hit at the beginning of the pandemic in the US.
Lindsay, who is Black, received the injection from
Michelle Chester, a Black physician at the hospital.
This photo-op was an attempt to build confidence for
the vaccines in the Black community, where there is
much distrust of the medical establishment.6
Senior US government officials have already received
the first dose of the Pfizer vaccine: Nancy Pelosi,
speaker of the House; Mitch McConnell, Senate
majority leader; Vice President Mike Pence and his
wife, Karen Pence; and the US surgeon general,
Jerome Adams. President elect Joe Biden and his wife,
Jill Biden, will receive injections on 21 December.
the bmj | BMJ 2020;371:m4924 | doi: 10.1136/bmj.m4924
President Donald Trump has neither received the
vaccine nor made a statement about vaccine
distribution.
Side effects
Both Moderna’s and Pfizer-BioNTech’s vaccines use
the new messenger RNA (mRNA) technology, but
Moderna’s vaccine can be kept cold in an ordinary
freezer, whereas the Pfizer-BioNTech vaccine must
be kept at –70°C.
Both vaccines require two injections: 21 days apart
for the Pfizer vaccine and 28 days apart for the
Moderna vaccine. Side effects have been reported
with both: pain at the injection site, muscle aches
and pains, and sometimes a slight fever.
A few anaphylactic reactions have been reported with
the Pfizer-BioNTech vaccine in the UK and the US.
The UK now advises that people with any history of
anaphylactic reactions should not receive the vaccine.
The CDC says that people who have had an allergic
reaction to an ingredient in the vaccines should not
receive the vaccine, while people who have not had
allergic reactions to injectable vaccines but have had
allergic reactions to food, pets, or medicines—but not
anaphylactic reactions—may receive it.
All who receive the vaccine should be monitored for
15 to 30 minutes after injection.7
Correction: On 22 December 2020 we corrected the headline to “FDA
authorizes Moderna vaccine” (not “approves”).
1 Grady D, Goodnough A, Weiland N. Moderna vaccine is second to get
cleared by FDA. New York Times 2020 Dec 19. https://www.ny-
times.com/live/2020/12/18/world/covid-19-coronavirus.
2 Coronavirus in the US: latest map and case count. New York Times 2020
Dec 20. https://www.nytimes.com/interactive/2020/us/covid-cases-deaths-
tracker.html.
3 Weise E. States were left scrambling after finding out they’d get 20-40%
less vaccine than promised. We now know why. USA Today 2020 Dec 19.
https://www.usatoday.com/story/news/2020/12/19/federal-vaccine-distri-
bution-discrepancy-states-less-doses/3960344001/.
4 Owermohle S. FDA says Pfizer vaccine vials hold extra doses, expanding
supply. Politico.com 2020 Dec 17. https://www.politi-
co.com/news/2020/12/16/pfizer-vaccine-extra-doses-447117.
5 Feuer W. CDC panel says frontline essential workers, people 75 years and
old should get covid vaccine next. CNBC.com 2020 Dec 20.
https://www.cnbc.com/2020/12/20/cdc-panel-says-frontline-essential-
workers-people-75-years-and-older-should-get-covid-vaccine-next.html.
6 Otterman S. “I trust science,” says nurse who is first to get vaccine in US.
New York Times 2020 Dec 14. https://www.nytimes.com/2020/12/14/nyre-
gion/us-covid-vaccine-first-sandra-lindsay.html.
7 Centers for Disease Control and Prevention. Covid-19 vaccines and severe
allergic reactions. Updated 19 Dec 2020. https://www.cdc.gov/coron-
avirus/2019-ncov/vaccines/safety/allergic-reaction.html.
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This article is made freely available for use in accordance with BMJ's website
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.
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