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A few days before the decision on emergency approval in the US, the FDA gave the vaccine a good rating from Biontech and Pfizer. It is said to have a high protective effect.
Mainz biotech company Biontech and its US partner Pfizer have overcome a major hurdle in the emergency approval of their corona vaccine in the US The FDA is not concerned about the use of the vaccine; it is effective and safe. FDA scientists examined data from their studies provided by Biontech and Pfizer and published their results in a lengthy document.
“Certificate with grade 1+”
The document shows that there is strong protection against Covid-19 only ten days after the first dose of the vaccine. There are no major security concerns. “This is what a certificate with a 1+ rating for a vaccine looks like,” Akiko Iwasaki, an immunologist at Yale University, told the New York Times.
Additionally, the FDA confirmed information from Pfizer and Biontech that their vaccine is 95 percent effective. It works for people of all ages, genders and ethnicities, as well as for risk groups with previous illnesses.
Even against the worst events
US authorities come to another conclusion: based on this, the active ingredient appears to prevent even the worst courses of Covid-19 after the second dose and offer protection after the first dose. And it also seems to work in people who were previously infected with the coronavirus. However, more research is needed for a “final statement”.
However, the FDA does issue a warning: For children and adolescents under 16, the data was as inadequate as for some other groups, such as pregnant women, to recommend the vaccine.
Serious side effects are rare
Side effects were also examined: the most common were injection site reactions, fatigue, and headache, followed by muscle pain, chills, joint pain, and fever. There were more serious reactions in only up to 4.6 percent of the participants. They occurred more frequently in subjects 12 years of age or older (4.6 percent) than in the group of people older than 55 years (2.8 percent). Experts suspected that this was due to the better immune defenses of the very young.
Unwanted side effects, particularly severe, that would have to be treated in the hospital, for example, were found in less than 0.5 percent of the test subjects, and these were as common in the group that received only a placebo as in the group that was actually vaccinated. That would indicate that they were not caused by the vaccine.
A decision is expected soon
Biontech and Pfizer filed an application with the FDA for emergency approval of their vaccine in November. On Thursday, an FDA advisory committee wants to address the vaccine, a decision is expected soon after.
The European Medicines Agency (EMA) is also currently advising on a recommendation for approval of the vaccine. The UK approved the vaccine last week and started vaccinating today.
With information from Arthur Landwehr, ARD-Studio Washington
