FDA approves US use of another COVID-19 vaccine

On December 17, a group of experts from the FDA's advisory board recommended that Moderna's COVID-19 vaccine be authorized for use during a pandemic. This decision paved the way for six million doses to be shipped on December 19 and 20. NDTV.

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The FDA is now expected to issue an Emergency Use Authorization (EUA) shortly, making Moderna the second such drug approved in a Western country.

Двадцать голосующих членов группы выступили «за» и один воздержался. «Против» не проголосовал никто.

They were asked to answer the question, "Based on the body of available scientific evidence, do the benefits of Moderna COVID-19 vaccine outweigh the risks when used in individuals aged 18 and over?"

The advisory board meeting comes at a time when the number of coronavirus deaths is rapidly approaching 310 in the world's worst-affected country, which began vaccinating healthcare workers and long-term care patients with Pfizer / BioNTech vaccine on December 000.

On the subject: COVID-19 vaccination begins in the US: how to prepare and what to expect

Both approved vaccines are based on advanced mRNA (ribonucleic acid messenger) technology, and both require a two-dose regimen.

Хотя уровень защиты от COVID-19 для обеих вакцин составляет 94-95% — намного больше, чем думали эксперты, — в настоящее время во всем мире есть несколько людей, у которых после вакцинации Pfizer развились серьезные аллергические реакции.

The US, with more than 17 million cases of the virus, is likely to be the first country to approve the Moderna vaccine. A small biotech firm in Massachusetts has teamed up with scientists at the US National Institutes of Health on the product and has received more than $ 2,5 billion from the US government for its efforts.

Protection from infection

A clinical trial involving 30 people showed that the vaccine was 400% effective in preventing COVID-19 compared to placebo; in young people it is slightly higher than in older people.

According to Jacqueline Miller, Moderna's vice president of infectious disease development, experts have good reason to believe that the vaccine will protect most people from infection, which is important from a public health perspective as it will prevent further transmission.

A review of all the available FDA data showed that "there were no specific safety concerns."

But on December 17, FDA spokesman Doran Fink said that if the EUA is issued, the agency will issue a special label warning of potential allergic reactions (such measures are to be used after two medical workers in Alaska developed a similar reaction to the Pfizer vaccine, and one of these were hospitalized Two health workers in the UK also had allergic reactions.

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The placebo dilemma

Moderna has been criticized by Stanford expert Stephen Goodman for its plans to offer the vaccine to trial participants who received placebo even before it becomes publicly available to their demographic.

This would deprive the test of a control group and reduce the quality of the data that could be extracted from it, as well as creating a bad precedent for future testing, he said.

But Tal Zachs, chief physician of Moderna, supported the proposal.

«Ни один из участников нашего испытания не станет «перепрыгивать» других, потому что у нас есть запасы материалов для клинических испытаний, срок годности которых истекает, их и расходуем», — сказал он, а затем сообщил, что участники находятся в группе высокого риска, один человек из группы плацебо даже умер от тяжелой формы COVID-19.

Side effects

The most common side effects associated with mRNA-1273 were: pain at the injection site, weakness, headache, muscle and joint pain, and chills.

Some of these symptoms have been classified as "serious".

Allergic reactions occurred in 1,5% of the vaccinated compared with 1,1% in the control group, but none of them were classified as severe.

On the subject: Pfizer Releases COVID-19 Vaccine Side Effects Report

На сегодняшний день известно о трех случаях паралича Белла (паралича лицевого нерва, чаще всего временного) в группе вакцинированных и одном — в группе плацебо.

The FDA said there was not enough information to determine if vaccination was the cause of the paralysis, but surveillance continues.

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