Say their submission to the European Medicines Agency was based on an advanced study in more than 2,000 adolescents that showed it to be safe
Employees work in the production of BioNTech/Pfizer’s Comirnaty vaccine at Allergopharma’s production facilities in Reinbek, Germany. Pic/AP
Pfizer and BioNTech have submitted a request for European Union drug regulators to extend the approval of the companies’ novel Coronavirus vaccine to include children ages 12 to 15, a move that could offer younger and less at-risk populations in Europe access to the shots for the first time.
In a statement on Friday, the two companies said their submission to the European Medicines Agency was based on an advanced study in more than 2,000 adolescents that showed the vaccine to be safe and effective. The children will continue to be monitored for longer-term protection and safety for another two years. BioNTech and Pfizer previously had requested their emergency use authorisation with the US Food and Drug Administration also be extended to children 12-15.
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German Health Minister Jens Spahn welcomed the news that the vaccine might soon get the green light for older children. “This can make a further real difference to our vaccine campaign, if approval is granted,” he said on the sidelines of a visit to a vaccine manufacturing plant in the German town of Reinbek.
US won’t release AstraZeneca
The US Food and Drug Administration will not release AstraZeneca’s coronavirus vaccine for export to other countries until it is sure the doses have been manufactured to US quality standards and will be safe and effective, a government official told CNN on Thursday. According to CNN, The White House said on Monday it would ship doses of AstraZeneca vaccine to other countries, including India, after a safety review by the FDA. AstraZeneca is yet to apply for emergency use authorisation (EUA) in the US, but it has been making tens of millions of doses in US in expectation it will apply for and receive EUA eventually.
France finds 1st cases of variant sweeping India
France has announced its first confirmed cases of the virus variant that is sweeping over India, just as the French president outlined a national reopening plan after six months of virus restrictions. The Health Ministry announced late Thursday night that three people tested positive for the new variant in the Bouches-du-Rhone and Lot et Garonne regions of southern France. All three had travelled to India, and are under medical observation.
Hong Kong health adviser warns of a fifth COVID-19 wave
A top Hong Kong public health adviser has warned of a potential fifth wave of COVID-19 infections emerging in the next couple of weeks after authorities identified the city’s first untraceable case with a mutant strain and evacuated hundreds from a residential block overnight.
Brazil tops 400,000 virus deaths
Brazil has became the second country to officially top 400,000 COVID-19 deaths, losing another 100,000 lives in just one month, as some health experts warn there may be gruesome days ahead when the Southern Hemisphere enters winter.
6,92,879
No. of new cases reported globally in the past 24 hours
149,910,744
Total no. of cases worldwide
3,155,168
Total no. of deaths worldwide
Source: WHO/Johns Hopkins
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