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. The results of its research have not yet been published. According to preliminary data, it is 95 per cent effective.
“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech’s COVID-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness”according to the statement.
The message adds that “the vaccine will be made available across the UK from next week.”
More than one and a half hundred SARS-CoV-2 vaccines are currently in development worldwide. Of these, only about a dozen have managed to reach the third phase of clinical trials. And only a few are approved for use – for example, China’s CanSino and Russia’s Sputnik – but in both cases only at-risk groups are vaccinated. There have been no approved vaccines in Europe and the United States so far. Even Sputnik, whose shipment was recently delivered to Hungary, can only be used in clinical trials until it is registered with the Hungarian authorities or the European Medical Agency.
Now the UK has officially approved the widespread use of the mRNA-based (a technology that has not yet been used in vaccines) anti-coronavirus vaccine from the drugmaker Pfizer and BioNtech. The results of the trials of the vaccine have not yet been published, but the company’s management reported that its effectiveness is about 95 per cent.
The third phase of the trial involved 43,661 volunteers, with a vaccine to placebo ratio of approximately 1:1. Of the 30 thousand participants, the data on which have already been processed, the researchers recorded 170 cases of the disease. 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 life-threatening side effects or any serious health problems. 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.
According to the UK government, the Pfizer vaccine will be available in the country as early as next week. At the same time, Pfizer filed documents with the U.S. regulators. The U.S. may approve the Pfizer vaccine ahead of schedule(at least two months after the vaccination trial), 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 infection, and in the case of severe disease, according to the company, it is 100 per cent.