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Wednesday 18 November 2020
Biontech and Pfizer announce more details about their Covid-19 vaccine: the effectiveness is 95 percent, and therefore even slightly higher than that of competitor Moderna’s vaccine. US authorities could soon issue an emergency permit.
According to the manufacturers, the crown candidate vaccine from the Mainz-based company Biontech and the American group Pfizer prevents 95 percent of Covid 19 diseases. After completing the analyzes of its latest large clinical study, an effectiveness of the 95 percent, the two companies announced. There are no security issues with the agent. Pfizer announced that it would apply for emergency approval from the US Food and Drug Administration.
Biontech and Pfizer also released positive data on the vaccine’s safety, calling it a milestone for emergency approval in the United States. The data must also be submitted to other regulatory authorities around the world.
The FDA could give the green light to commercialization starting in December, as announced by a representative of the crisis team created by the US government. Medical personnel and members of risk groups could have access to vaccines from of the first fortnight of December. According to US authorities, the vaccine should be available to the general public in the United States beginning in April.
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. After an initial interim analysis, the vaccine had shown 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.
Serious side effects rarely occurred
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 8 in the vaccinated group. There have been 10 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 resolved quickly.
The only serious side effect was fatigue in more than 2 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 adults over 65, the observed effectiveness 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), is even supposed to be tested at a dose of just 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.
