The US Food and Drug Administration (FDA) has given them emergency use approvals for this age group, the manufacturers said on Friday.
Previously, after hours of discussion, an advisory board to the FDA unanimously voted in favor of it. This could soon start vaccinations against the corona virus in this age group in the USA. A few days ago, the US government said that this would be expected from around June 21st.
Previously, BioNTech/Pfizer’s vaccine was approved in the United States for children ages five to 11, and Moderna’s vaccine for people ages 18 and older. The Moderna vaccine has now also received emergency approval for children and adolescents between the ages of 6 and 17.
There is currently no corona vaccine approved for very young children in the EU. The European Medicines Agency EMA in Amsterdam is currently examining whether the vaccine from the manufacturer Moderna (Spikevax) can also be approved for children under the age of six. Such a test has not yet started for the vaccine from the manufacturers BioNTech and Pfizer. According to the EMA, the manufacturers have not yet submitted a corresponding application for an extension of the approval.
EU Medicines Agency is reviewing Moderna’s Omicron vaccine
The EU medicines agency EMA has initiated the test procedure for the corona vaccine from the US manufacturer Moderna, which has been adapted to the omicron variant. The vaccine is intended to provide better protection against infection with the virus and its omicron variant, as the EMA announced in Amsterdam on Friday. Experts will first review data from laboratory studies, composition, manufacturing and control process data.
On June 8th, the US company presented the first data on the effectiveness of its adapted corona vaccine. The 437 subjects who had received the new preparation as a second booster had significantly more neutralizing antibodies after one month than after a booster vaccination with the conventional preparation, especially against Omikron.
According to the accelerated review process, data from tests and studies are continuously evaluated, even if not all the data is available and no application for approval has yet been submitted. The rapid procedure is intended to ensure that the health authorities of the EU countries have adapted vaccines in good time before a possible new wave of infections in autumn.
The EMA only started the test procedure for a corona vaccine adapted to virus variants from the manufacturers Pfizer and BioNTech on Wednesday. It is not known how long the exams will last. So far, no vaccine has been approved in the EU that also targets variants of the corona virus.
BioNTech shares were temporarily down 3.1 percent in NASDAQ trading at $125.14, while Pfizer shares fell 2 percent to $46.53 on the NYSE and Moderna shares on the NASDAQ up 5.75 percent to $128.03.
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