The FDA granted emergency approval for Pfizer and Biotech's corona vaccine

On Friday, the US Food and Drug Administration approved the vaccine for emergency use in people 16 and older. It is now expected that the Ministry of Health will approve the vaccine for emergency use in Israel as well

On December 31, 2019, the World Health Organization (WHO) announced an outbreak of a mysterious pneumonia in China, which later became a global epidemic. It soon became clear that the disease, COVID-19, is caused by a new corona virus, which in February 2020 was named SARS-CoV-2. On Friday (Saturday, Israel time), less than a year after the first publications about the outbreak of the epidemic, Granted by the United States Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the vaccine of the companies Pfizer (Pfizer) and BioNTech (BioNTech) against the virus. The approval was received following the recommendation of FDA Vaccine Advisory Committee On Thursday.

Before the announcement of the emergency authorization, and after the committee's recommendation, the Trump administration - Expected - Tried to damage the approval process and public trust in it: White House chief of staff, Mark Meadows (Meadows), Threatened the head of the FDA, Stephen Hahn, that if the vaccine is not approved by the end of the day Hahn will be forced to submit his resignation. The FDA anyway Plan to announce on Saturday morning on the granting of the emergency approval for the vaccine, and brought forward the announcement of this to Friday evening, apparently following the threat.

With the decision to grant emergency approval for vaccination, the vaccination campaign in the United States will begin in the coming days. Donald Trump (Trump) said that the first dose of the vaccine will be given in the United States within "Less than 24 hours". The vaccine will be given to those aged 16 and over and according to The recommendation of the American Center for Disease Control and Prevention (theCDC) The first to receive the vaccine will be the employees of the health system and the elderly in assisted living and nursing facilities.

In the first phase, only about three million vaccine doses will be given in the United States. Pfizer announced that it could supply By the end of 2020 up to 50 million portions, which will be enough for 25 million people worldwide, since the vaccine requires two doses that are given three weeks apart. About half of these doses are intended for the United States, which even before knowing if the vaccine was effective and safe, purchased 100 million doses from Pfizer and Biotech, for nearly two billion dollars, with an option to purchase another 500 million doses of vaccine. The rest of the vaccine doses needed to vaccinate the entire population will probably be completed by the United States from the Moderna company, whose vaccine against Corona is expected to receive emergency approval next week.

The State of Israel invited 8 million vaccine doses from Pfizer and Biotech and another 6 million vaccine doses from Moderna. After the FDA's approval, it is expected that the Ministry of Health will also approve the Pfizer and Biontec vaccine, and that a vaccination campaign will soon begin in Israel as well. Even before the United States, the vaccine was approved for emergency use in Great Britain, QThe second person vaccinated in it 81-year-old William Shakespeare was not part of the experiment. The first vaccine, who also deserves mention, was 91-year-old Margaret Keanan. Canada, Bahrain and Saudi Arabia also granted emergency approval for the vaccine before the United States.

The way to approval

Since the outbreak of the epidemic until today (12/12/2020) Discovered all over the world Over 71 million corona cases and the number of deaths from the disease exceeded 1.6 million. in the United States alone The total number of cases is over 15.8 million people, and a total of 295,539 patients died there in the meantime. More than 13,000 of the dead They died the week the vaccine was approved which could have prevented these cases: according to the data they published in full transparency Pfizer and Biotech companies And according to FDA analysis, after two doses of the companies' vaccine protects against COVID-19 with 95 percent efficiency. No difference was observed in the effectiveness of the vaccine in the different groups tested: men and women; elderly and young; and volunteers from risk groups for corona, such as those with obesity, diabetes or high blood pressure.

The vaccine appears to be relatively safe. Currently, no life-threatening side effects have been discovered among the vaccinated. The most common symptoms, which usually lasted several days, were pain at the injection site, fatigue, headache, chills, joint pain, and fever. The side effects were more common after the second dose and in people under the age of 55. In the UK, where thousands of people have already started to be vaccinated with the Pfizer and Biontec vaccine, two vaccinated health system workers had an allergic reaction shortly after receiving the vaccine. Both have a medical history of severe allergy, requiring them to carry an epinephrine (epiphane) syringe for emergency treatment in the event of a severe allergic reaction. The FDA recommends not vaccinating people with a history of a severe allergic reaction to one of its components.

The information on the effectiveness and safety of the vaccine was received From phase three of a huge clinical trial, which includes more than 44 thousand volunteers and takes place in different places around the world. Clinical trials usually include only a few hundred or thousands of people, although in cases where one wants to greatly increase the safety factor, tens of thousands of experimenters are recruited. This was done in trials of the corona vaccine as well as, for example, in trials of the new vaccines against the rotavirus thatOver 60 thousand babies participated in them.

The decision to grant permission for emergency use of the vaccine was made with transparency, which arouses envy when considering the conduct of the Ministry of Health in particular and the government of Israel in general. After documents related to the vaccine were publicly released, the FDA's Vaccine Advisory Committee met on Thursday to discuss its approval live. the committee Dana in ethical issues related to the approval of the vaccine, on the way toMonitoring the vaccinators and questions raised by various experts and public representatives. Pfizer and the FDA then presented details about the vaccine and the study. Finally, after about 9 hours, the experts on the committee discussed the vaccine and voted that the vaccine is effective and safe and that they recommend approving it for emergency use in people 16 and older. 17 experts voted in favor of the recommendation, four against and one abstained. The vote was not unanimous, probably because some experts It interfered with the vaccine being approved for 16 and 17 year olds as well. According to them, there is still not enough information about the effectiveness of the vaccine in these age groups, and teenagers will not be the first priority to receive the vaccine anyway.

The FDA, as is almost always the case, implemented the recommendations of its expert committee and granted emergency use approval for the vaccine. Contrary to full approval (FDA approval), Authorization for emergency use is approval given to treatments that have shown that their benefit outweighs the risk, but that not enough evidence has yet been accumulated to give them full approval. It is given only in emergency situations And only for treatments that do not have an alternative treatment that has already been approved. Pfizer and Biotech companies Hope their vaccine will be fully approved during the next year. They think they will have enough data Submit an application for such approval as early as April 2021. If approved, other corona vaccines will no longer be able to receive approval for emergency use from the FDA. It seems that the biological institute should hurry.

Good news, though

Despite the emergency approval given to Pfizer and Biotech's vaccine, called BNT162b2, in several countries, it probably won't stop the epidemic anytime soon. The number of vaccine doses currently available in the world is very low, and many populations in which the safety of the vaccine has not yet been tested will not be able to be vaccinated in any case: people who are pregnant, breastfeeding, immunosuppressed, children and more. Also, some people are afraid to get vaccinated for various reasons, including lies, rumors and intimidation spread by anti-vaccines. As long as not enough people are vaccinated, the virus will continue to spread in the world and endanger lives, and we will have to continue to take other measures to stop it and maybe even suffer confinement.

Also, currently the studies show that the vaccine prevents disease, but there is still no evidence from human trials showing that it also prevents infection with the virus. It is possible that the vaccinated are not sick, but they may be infected with the virus without symptoms and thus pass it on. It is likely that the vaccine at least reduces the spread of the virus, but until we know this for sure, we will have to continue to maintain physical distance and wear masks in the presence of strangers, and we will have to wait with ideas like giving the vaccinated people "Green passport".

However, from the evidence and data already available it appears that the Pfizer and Biontech vaccine is safe and effective. Moderna's vaccine, which is based on similar technology (RNA vaccine) and will probably receive emergency approval from the FDA next week, also appears to be safe and effective. Personally, I will stock up on one of them as soon as I get the chance. If your health allows it, I recommend that you also get vaccinated.

the record Originally posted on the blog "Noam box - biological thoughts” by Dr. Noam Levitan.

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