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‘Moderna’ gets first green light

Newsman: The breakthrough to fight the Covid-19 pandemic, a second coronavirus vaccine for emergency use authorization got the green signal today. The vaccine candidate developed by Moderna developed the vaccine with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The company also received funding for the research and development from Operation Warp Speed. Moderna corona virus vaccine can be stored to a regular deep freezer at the kitchen under minus 4 degree temperature whereas Pfizer-BioNTeck need nearly minus 100 degree temperature to be stored. Besides, Moderna Vaccine will have the longer expiration date of   30 days instead of two weeks like Pfizer- BioNTech. If authorized, the vaccine would be for adults, 18 and older.

 It seems that the Modern vaccine will have more advantages not only for it storage temperature, extended expiration date of use but the name of National Institute of health American tagged with it.  As expected, an independent panel of advisers to the Food and Drug Administration overwhelmingly recommended that the agency authorize Moderna’s Covid-19 vaccine for emergency use on Thursday, which brings the United States closer to adding a second vaccine to its toolkit in fighting the pandemic. Last week, the FDA authorized Pfizer-BioNTech’s Covid-19 vaccine for that age 16 and above. Nearly 3 million doses of that vaccine were on target for delivery this week to health care workers and people in long-term care facilities. A second batch of doses has been reserved for the second shot, administered 21 days after the first.

Unlike the Pfizer- BioNTech vaccine candidate, Moderna’s Covid-19 vaccine got the recommendation with zero negative votes, though one was abstention. Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 20 to 0 in favor of recommending authorization. The FDA is expected to agree with the committee’s recommendation, and an emergency use authorization could come as soon as Thursday evening or Friday. The center for disease control (CDC)’s   advisory committee for immunization and practices (ACIP) now to finally recommend Moderna’s  coronavirus Vaccine for the emergency use authorization.

US department of Food and Drug administration

However the VRBPAC found the almost same amount of efficacy of this vaccine as the Pfizer-BoiNtech vaccine that has been authorized for emergency use authorization. And the side effects are likely to be similar as t the Pfizer-BoiNtech vaccine.

Two other vaccines in Phase 3 clinical trials, from AstraZeneca and Johnson & Johnson, “will ensure that more Americans will get shots in their arms.” Results from those trials are expected in early 2021.

Moderna’s vaccine is also given in two doses, but 28 days apart. Clinical trials showed the vaccine was 94 percent effective in preventing symptomatic illness within two weeks after the second dose. Pfizer’s has been shown to be similarly effective.

Moderna pioneered the messenger RNA research 13 years ago. But the vaccines from Pfizer and Moderna both work in the same way, using tiny snippets of genetic code called messenger RNA, or mRNA, to prompt the immune system into producing antibodies to the coronavirus, without using bits of the virus itself. But these are the first such vaccines to be authorized for use.

During the advisory committee meeting Thursday, representatives from Moderna said that among the more than 30,000 clinical trial participants, there were no cases of anaphylaxis that appeared to be related. (One participant developed anaphylaxis 63 days after getting the second dose. The reaction usually occurs immediately after exposure to an allergen.)

Three people in Moderna’s clinical trials who developed swelling in the face also had fillers, either in their cheeks or lips. Those procedures had been completed between two weeks and six months before vaccination.

Other milder side effects were indeed reported among those who received the Moderna vaccine, especially after the second dose.

The most common were pain, swelling, redness and tenderness in the injection area. Headache, fatigue, weakness, chills, nausea and joint pain were also reported. Bell’s palsy, a facial paralysis, was reported in four study participants. Three were in the vaccine group, and one had received the placebo.

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