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Mainz biotech company Biontech and its partner Pfizer have overcome the decisive hurdle to a possible approval of their corona vaccine in the US After a final analysis of the crucial study, the vaccine showed 95 percent protection against Covid -19, the two companies said.
They also released positive data on the safety of the vaccine, which they called a milestone for emergency approval in the United States. Now they want to send the request to the US health authority FDA in a few days. The data must also be submitted to other regulatory authorities around the world.
Last week, Biontech and Pfizer became the first companies in the world to submit successful efficacy data from the pivotal study with a corona vaccine. According to an initial interim analysis, the vaccine showed more than 90 percent efficacy in protecting against Covid-19. On Monday, the American biotech company Moderna followed suit, announcing that its vaccine offers 94.5 percent protection against Covid-19.
The United States FDA had set 50 percent effectiveness as the minimum value for possible approval. Regarding safety, the authority published new guidelines for emergency approval in October: Safety data is expected for at least two months from about half of the study participants after the administration of the last dose of vaccine. The final analysis of the Biontech and Pfizer study, which includes more than 43,000 participants, is based on 170 cases of Covid-19 among the subjects. Of these, 162 occurred in the placebo group and eight in the vaccinated group. There have been ten serious cases of Covid-19, one of them in a vaccinated participant.
The vaccine was well tolerated and there were mostly mild to moderate side effects that quickly disappeared. The only serious side effect was fatigue in more than two percent of those vaccinated, of which 3.7 percent were affected after the second dose. Protection was uniform regardless of age and ethnic origin. In older adults over 65, the observed efficacy was greater than 94 percent.
“The data shows that our vaccine with a 30 microgram dose can produce a high level of protection against Covid-19 only 28 days after the first dose,” said Biontech chief Ugur Sahin. The vaccine is given twice at a dose of 30 micrograms each. Therefore, the dose is lower than that of the Moderna vaccine with 100 micrograms each. The vaccine from the Tübingen-based biotech company CureVac, which, like those from Biontech and Moderna, is based on so-called messenger RNA (mRNA), will only be tested at a dose of twelve micrograms. However, the fundamental study of Curevac has not yet begun.
Biontech and Pfizer confirmed that they plan to produce up to 50 million doses of vaccines this year and up to 1.3 billion next year. The European Union has already insured up to 300 million cans and delivery could start later this year. The United States signed a contract with the company to supply 100 million cans valued at around $ 1.95 billion, with the option to purchase an additional 500 million cans. (Reuters / apa / red)
