The UK government has approved an anti-coronavirus vaccine from Pfizer and BioNTech. It is the first vaccine to be approved for widesprea...
The UK government has approved an anti-coronavirus vaccine from Pfizer and BioNTech. It is the first vaccine to be approved for widespread unrestricted use in Europe outside of clinical trials. The results of her research have not yet been published. According to preliminary data, it is 95 percent effective.
Now in development around the world, there are more than one and a half hundred vaccines from SARS-CoV-2. Of these, only about a dozen managed to enter the third phase of clinical trials. And only a few are approved for use - for example, the Chinese CanSino and the Russian Sputnik - but in both cases so far only people from risk groups are vaccinated. There are still no approved vaccines in Europe and the United States. Even Sputnik, a batch of which was recently shipped to Hungary, can only be used therein clinical trials until it receives registration from the Hungarian authorities or the European Medical Agency.
The UK is now the first to officially allow widespread use of the anti-coronavirus vaccine. The government approved the use of mRNA-based development by Pfizer and BioNTech, a technology that has not yet been used in vaccines. The test results for this vaccine have yet to be released, but the company said it was around 95 percent effective.
In the third phase of the trial, 43,661 volunteers participated, with a ratio of vaccine to placebo groups of approximately 1: 1. Of the 30 thousand participants, the data for which have already been processed, the researchers recorded 170 cases of the disease (previously they were going to stop the trial after 164 cases - read about where this estimate came from, read our blog "The Magic of Numbers" ). Of these, 162 were in the placebo group and 8 were in the vaccine group. At the same time, only 10 people developed a severe form of COVID-19: 9 from the placebo group and 1 from the vaccine group.
In addition, 19 thousand participants have passed more than two months from the date of vaccination - and during this time, the researchers did not notice any side effects that could threaten their lives or health. They carried out an accurate accounting of side effects in only 8 thousand volunteers - and the most common was fatigue after vaccination, it was experienced by 3.7 percent of study participants. Other effects were less severe or even less common.
Pfizer's vaccine will be available in the country next week, UK government officials said. In parallel, Pfizer has filed documents with the US regulatory authorities. They usually require at least half of the subjects to be vaccinated after at least two months before the vaccine is registered. This is to make sure it is safe. Nevertheless, in the context of a pandemic, this period was shortened, and in the United States, the Pfizer vaccine can be approved early, approximately on December 10.
Together with Pfizer, Moderna, the manufacturer of another mRNA vaccine, also filed for registration. Its effectiveness is similar to the Pfizer vaccine when it comes to contamination, and in the case of severe disease, according to the company, it is 100 percent.
