The FDA has finally approved Moderna’s vaccine for Corona

Modern’s Vaccine Launches: The US Food and Drug Administration (FDA) has granted emergency approval for the company’s Corona vaccine, a pioneer in mRNA vaccine technology. This final approval comes after approval by a panel of FDA experts who have unanimously recommended granting the vaccine an emergency approval. The vaccine, which has been tested on tens of thousands of healthy and elderly people and those suffering from background diseases, has been found to be safe and highly effective. Israel is expected to receive vaccines that will suffice for 3 million people.

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The FDA has determined that based on the months of trials, the high safety and efficacy profile, the vaccine is suitable for use in humans in the shadow of the severe corona epidemic that has so far led to nearly 1.7 million deaths worldwide, and about 76 million cases. The FDA has approved another precedent-setting move in which those who participated in a modern experiment and received a placebo vaccine (without an active ingredient) will be notified and allowed to receive the real vaccine. In addition, unlike the Pfizer vaccine given from the age of 16 and up, the modern company vaccine will be available from the age of 18.

The modernity vaccine The modernity vaccine Photo: AFP

The emergency approval for Moderna’s vaccine is given in parallel with the continued monitoring of the vaccinated in the framework of “Phase 4”, which will last about two years. The company has pledged to regularly update the drug authorities around the world on any serious side effects that are discovered among the vaccinated, or if other problems arise such as a decrease in vaccine effectiveness.

On Tuesday this week, the FDA completed a preliminary test that confirmed that the modern vaccine is safe and effective for use in humans: And half of them got the real shot. None of the vaccinated or medical staff who accompanied the study knew who received which vaccine.

The vaccine begins to protect as early as a week after the first dose

At the end of the results, it was found that the effectiveness of the vaccine reached 94.1%, similar to the Pfizer vaccine, and that none of the vaccinated developed a serious illness. The vaccine begins to protect as early as one week after the first dose, however the full protection appears two weeks after the second dose. The company began producing millions of vaccine doses several weeks ago, thanks to the unique production technology based on the mRNA molecule, which makes it possible to produce vaccines in large quantities and quickly.

Modern company Modern company Photo: Moderna

Israel has anticipated and purchased 6 million vaccine doses from Modern, which are expected to arrive in the coming weeks and will be enough to vaccinate 3 million people. The modern vaccine is given in two doses 3 weeks apart. Moderna’s vaccine also requires a very low cooling temperature of minus 15 degrees, but less than that of Pfizer which requires minus 70 degrees. The vaccine can also be stored in standard vaccine refrigerators operating at a temperature of 2 to 8 degrees, for 30 days (as opposed to 5 days in Pfizer vaccines).

Moderna’s trials were funded through a $ 483 million grant from the US Medical Development Authority, which the company used to employ another 150 workers, and it plans to produce tens of millions of rations by 2021. To further increase the vaccine’s production capacity, Moderna signed a 10-year agreement Years with the Swiss pharmaceutical company lonza, which aims to reach a production rate of about a billion vaccine doses a year.

Modern and Pfizer vaccines are considered groundbreaking, and are among the first to use a genetic molecule called mRNA. Unlike traditional biological-based vaccines, such as vaccines that require egg or bacterial growth, Pfizer and Moderna vaccines are all synthetically produced, leading to their extremely rapid production that allows hundreds of millions of vaccines to be issued in a short time, .

Meanwhile, the most extensive vaccination campaign ever in Israel is expected to begin tomorrow: first, medical teams will be vaccinated in large hospitals and at the HMOs’ vaccination points around the country, and from Monday, the vaccination of at-risk populations will begin. In about two weeks, vaccination of the rest of the population will begin. According to the plan, the funds treated at least 60,000 people a day. To date, about 500,000 vaccines have been brought to Israel, and in the coming weeks hundreds of thousands of Pfizer vaccines are expected to arrive. The date for the arrival of modern vaccines has not yet been set.