We will ask for an emergency permit for the vaccine for...

We will ask for an emergency permit for the vaccine for...
We will ask for an emergency permit for the vaccine for...

Pharmaceutical giant Pfizer announced today (Friday) that at the end of November it will probably submit to the US Food and Drug Administration (FDA) an application for approval of an “emergency use” of the vaccine for corona that it is developing in collaboration with the German company Biontech. USA, to be held on November 3, as President Donald promised.

Read more in Calcalist:

The US Food and Drug Administration (FDA) requires data on the safety of vaccine use for at least two months before issuing the emergency clearance. To date, no unusual side effects have been reported in Pfizer trials of the vaccine.

Pfizer has created the BNT162 vaccine, which contains various proteins that, when injected into the body, make it “think” that it is a real corona virus, and produce antibodies against it that will neutralize the virus.

The company expects important information about the effectiveness of the vaccine later this month, and information about its safety in the third week of November. Assuming the results are positive, Pfizer will apply to the FDA for an emergency approval to use the vaccine in the United States.

Pfizer estimates that by the end of 2020, it will be able to produce millions of vaccine doses, and hundreds of millions of vaccines by 2021.

Pfizer Headquarters in New York Photo: AP

Over 90 vaccines are currently in pre-clinical trials, testing their efficacy, safety and efficacy on animals. These stages include an experiment in animals from the rodent group (mice and laboratory rats) and later the vaccine was also tested in mammals up to the highest level of mammals closest to man – the monkeys.

The phases of clinical trials are being performed in humans: In the first phase of testing the safety of the vaccine and the safe doses for humans, there are now 29 vaccines. In Phase 2 of the trials there are currently 14 vaccines. At this stage, the safety of the vaccine is being tested on a larger group of hundreds of volunteer subjects, including the effectiveness of the vaccine, ie the formation of antibodies and T cells that are supposed to neutralize the corona virus and signal the immune system to destroy it before it duplicates and causes disease.

The last and most important vaccination phase is Phase 3, in which the effectiveness and safety of the vaccine is tested on tens of thousands of subjects. At present, there are 11 companies, the leading ones of which include Moderna, Pfizer, the British Astraznica, the Chinese Casino and Sinopharm and the Russian Sputnik 5.

In China, the administration has approved to start vaccinating part of the population with the two Chinese vaccines from the companies Kensino and Sinopharm. Beginning in August, the vaccines began to be accepted by military personnel who agreed to it. Russia, Saudi Arabia, Pakistan and the United Arab Emirates have also begun vaccinating the residents who volunteered to be the first to receive the corona vaccine.

It is estimated that more than half a million residents in these countries have so far been vaccinated with Chinese and Russian corona vaccines, in addition to about 300,000 who have received the vaccines in the various studies. To date, no infection of any of the detainees has been reported. The vaccines have so far been found to be safe, and the side effects recorded included fever, redness and mild pain at the injection site, which passed within a few days.

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