Pfizer and BioNTech will apply to the US authorities on Friday for approval to allow the use of the COVID-19 vaccine, pharmaceutical companies said. If approved, the first vaccinations could take place in December.
The companies said in a statement that the submission of the application could “potentially allow the vaccine to be used in high-risk populations in the US by mid to late December 2020.”
The vaccine will first go to high-risk groups
The application is based on the results of the third phase clinical trials of the BNT162b2 vaccine, which showed the effectiveness of the vaccine at the level of 95%. and showed no serious side effects.
Ugur Sahin, head of BioNTech, the German company that developed the vaccine from Mainz, said the application to the US Food and Drug Administration (FDA) is “a key step in making a potential vaccine available to the global population as soon as possible.” He added that his company, together with Pfizer, also cooperates with the European Medicines Agency (EMA) and the regulator in Great Britain on an ongoing basis. In the coming days, similar applications will also be sent to agencies in other countries, including in Australia, Canada and Japan.
If the response from the authorities is positive, the vaccine will be made available to high-risk groups in the first place: medical staff, seniors and people with diseases that increase the risk of dying from COVID-19. Each patient will receive two doses of the vaccine three weeks apart.
In 2021, 1.3 billion doses will hit the market
According to company estimates, 50 million doses of the preparation may hit the market this year, and 1.3 billion next year. According to the plans, distribution is to start hours after obtaining the permit.
On Friday, the Reuters agency said that under the Pfizer and BioNTech agreement with the European Union, Brussels will pay at least 3.1 billion euros for 200 million doses of the vaccine, or 4.65 billion if it uses the option to purchase additional 100 million doses. According to Reuters sources, companies will have to pay heavy compensation if some of the supplies ordered by the EU are redirected to the US.
Last week, Prime Minister Mateusz Morawiecki met with representatives of Pfizer in Poland. It was devoted to cooperation in the preparation of the purchase and distribution of COVID-19 vaccines.
– We want to start vaccinations from high-risk groups – mothers, fathers, grandmothers, from our seniors, from those most exposed to the coronavirus, but also from medical personnel and uniformed services – declared the Prime Minister.
On Monday, the effectiveness of the COVID-19 vaccine at 94.5 percent. the American company Moderna informed; The vaccine projects prepared by the British-Swedish company AstraZeneca in cooperation with the University of Oxford and by the American concern Johnson & Johnson are also very advanced.
On Tuesday, the European Commission approved a deal with the European pharmaceutical company CureVac, which initially foresaw the purchase of 225 million doses of the COVID-19 vaccine on behalf of all EU Member States and the option to order a further 180 million doses once research proves the vaccine is safe and effective. At the beginning of the week, the President of the European Commission, Ursula von der Leyen, expressed her hope that contracts with the American company Moderna regarding the purchase of COVID-19 vaccines will be finalized quickly. The talks so far concerned the supply of up to 80 million doses with the option of obtaining another 80. The Commissioner also announced that a contract for the supply of up to 300 million doses of a vaccine developed by Pfizer and BioNTech will be signed later this week.
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