The FDA is expected to Authorize the Moderna COVID-19 Vaccine for Emergency Use Friday
Photo illustration: COVID-19 image, Wikimedia, Logo, Courtesy of Moderna
The outside panel of experts, VRBPAC (Vaccines and Related Biological Products Advisory Committee) met Thursday and discussed the Moderna vaccine. They recommended that the Food and Drug Administration (FDA) approve the vaccine. The Chief adviser of Operation Warp Speed, Dr. Moncef Slaoui, in an interview with MSNBC, said that an emergency use authorization (EUA) for the COVID-19 vaccine can be expected Friday.
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The anticipated approval comes on the heels of the EUA granted to the Pfizer/BioNTech vaccine a week ago. Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) jointly developed the vaccine. On Tuesday, the FDA published a detailed analysis of the safety and efficacy data from an ongoing Phase 3 randomized double-blinded and placebo-controlled trial of Moderna’s mRNA vaccine. It confirmed the earlier results published by the biotech company on November 16, 2020, that their vaccine is 94.5% effective against the coronavirus. Of the ninety-five COVID-19 cases reported, 15 were older adults (ages 65+). Twenty participants were from diverse communities (including twelve Hispanic or Latina, four Black or African Americans, three Asian Americans, and one multiracial).
The FDA analysis provides additional details on the vaccine efficacy by age. For participants 18 -64 years old, it was 95.6% effective; for those above 65 years of age, it was 86.4%. The FDA also examined data from 7-week and 9-week follow-up studies. Critical safety data from this later submission, including death and other serious adverse events, were independently verified and confirmed. The most common adverse reactions associated with the vaccine were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%). Severe adverse reactions occurred in 0.2% to 9.7% of participants and were more frequent after the second dose than after the first. Such occurrences were generally less frequent in participants over 65 years of age as compared to younger participants. The data also suggests the vaccine may protect against asymptomatic infections.
The Moderna vaccine is also messenger RNA (mRNA) based like the BioNTech/Pfizer vaccine. An article published in the Journal of American Medical Association explains that a person receives part of the coronavirus’s genetic code in mRNA vaccine, tricking the body to make copies of the ‘spike’ protein, which educates the immune system to produce antibodies. The body’s immune system can then detect these proteins and create a defensive response when confronted with the actual virus.
Like the BioNTech/Pfizer vaccine, the Moderna vaccine also requires two shots, three weeks apart. Unlike the BioNTech/Pfizer vaccine, which needs to be stored at -70 to -80 degrees Celsius (94 degrees below zero Fahrenheit), this vaccine can be stored at -4 degrees Fahrenheit, which regular refrigerators can handle. The vaccine also has a longer shelf life of 30 days in the fridge, and it will last 12 hours at room temperature. Moderna vaccine thus has an advantage over Pfizer’s because of the relative ease of handling. Another story on Medium with additional details on the Moderna vaccine can be accessed here.
Moderna Joins Pfizer With Promising News About mRNA Vaccine.
One or both COVID-19 vaccines may become available soon.
medium.com
One healthcare worker in Alaska who received the BioNTech/Pfizer vaccine on Tuesday had a severe allergic reaction. She has recovered. A second worker had a less severe reaction Wednesday, was treated and quickly recovered. The Alaska cases echo two similar episodes of severe but non-fatal allergic reactions to the vaccine in the United Kingdom.
Moderna’s announcement comes when 245,033 new cases, 113,090 hospitalizations (21,936 in ICU, 7,778 on ventilators), and at least 3,611 coronavirus deaths were reported in the United States on December 16, 2020. US News reports that more than a third of Americans now live in areas where hospitals are critically short of intensive care beds. Conditions are even more dire across much of the Midwest, South, and Southwest, where intensive care beds are either full or fewer than 5 percent of beds are available. Critical care in many hospitals is being rationed. If conditions do not improve, caring for needy non-Covid patients may become difficult or impossible.
Operation Warp Speed, the government agency tasked with overseeing the development, manufacture, and distribution of a safe and effective COVID-19 vaccine, deserves credit for the massive logistical operation to deliver the Pfizer vaccine. The agency will now undertake a similar mission to distribute the Moderna vaccine. Between the two vaccines, Dr. Moncef Slaoui expects to immunize 20 million Americans in December.
The New York Times maintains an interactive vaccine distribution tracker [1] based on federal agency data. As of now, it shows the first doses of the Pfizer vaccine allocated to the various states. It should be updated as more data becomes available.
Pfizer has delivered 6.4 million doses of the vaccine. U.S. government is keeping 50,000 doses in reserve. At two doses of the vaccine per person, 2.9 million frontline healthcare workers and residents, and staff of long-term care facilities could be vaccinated with the remaining quantity. The agreement between the U.S. government and Pfizer was for 100 million doses. The Department of Health and Human Services (HHS) has made an agreement with Moderna to acquire an additional 100 million doses of their COVID-19 vaccine, bringing the total to 200 million. The extra doses would provide for continuous delivery through the end of June 2021. The combined total of 300 million doses from Pfizer and Moderna would be enough to vaccinate 150 million of the U.S. population. After passing up a chance to lock in a contract this summer, U.S. officials are negotiating with Pfizer for additional quantities of their vaccine. Unless one or more vaccines become available for use soon, it will be the end of 2021 when the rest of the population could expect to be vaccinated.
According to Dr. Steven Gordon, an Infectious Disease Specialist at the Cleveland Clinic, while the emergence of COVID-19 vaccines is exciting news, we are still in the thick of the pandemics. In spite of the COVID fatigue, he urges people to keep their guard up. “Wearing a mask is currently the greatest non-pharmacological measure we can do until a vaccine is readily available.”
