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EU regulator to decide on Pfizer/BioNTech Covid-19 jab by Dec 29

EU regulator to decide on Pfizer/BioNTech Covid-19 jab by Dec 29

AFP
Frankfurt am Main
Europe’s medicines regulator said on Tuesday it would decide by December 29 whether to grant emergency approval to a Covid-19 vaccine developed by Germany’s BioNTech and its US partner Pfizer, ahead of a rival treatment from Moderna.
The European Medicines Agency (EMA) confirmed that it had received formal applications from both vaccine makers seeking the green light for their experimental jabs.
“If the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine,” the Amsterdam-based agency said it could conclude its assessment of the BioNTech/Pfizer shot in an extraordinary meeting on 29 December “at the latest”.
A separate meeting to assess the Moderna shot would take place on January 12 at the latest, it added.
Large-scale trial data released last month showed that both vaccines were safe and around 95 percent effective against Covid-19.
European Commission spokesman Stefan de Keersmaecker told reporters that once the EMA had given regulatory permission, formal authorisation from Brussels would follow “very quickly”, probably “in a matter of days”.
Although both vaccines are being assessed in an accelerated process known as a “rolling review”, the latest timeline suggests Europeans would be lucky to receive the first jabs before the year is over.
BioNTech/Pfizer and Moderna have also applied for emergency use authorisation in the United States, where Americans are expected to start getting vaccinated around mid-December.
UK regulators, who because of Brexit no longer have to wait for the EMA’s okay, are also in the process of considering emergency approval of the BioNTech/Pfizer vaccine.
BioNTech and Pfizer said they had asked the EMA for “conditional market approval” (CMA) of their vaccine on Monday, after filing a request for emergency authorisation in the US on November 20.
If approved by the EMA, the vaccine could potentially be rolled out “in Europe before the end of 2020”, the companies said in a statement.
“We have known since the beginning of this journey that patients are waiting, and we stand ready to ship Covid-19 vaccine doses as soon as potential authorisations will allow us,” Pfizer CEO Albert Bourla said.
A CMA can be granted “in emergency situations in response to public health threats”, the EMA says on its website.
Fellow vaccine frontrunner Moderna, a US biotech firm, meanwhile said it had sought emergency approval for its Covid-19 shot in both the US and Europe on Monday.
The BioNTech/Pfizer and Moderna vaccines have been developed at breathtaking speed as part of an unprecedented effort to end a pandemic that has killed more than 1.4 million people worldwide and devastated the global economy.
Both are based on a new technology that uses mRNA (messenger ribonucleic acid) to deliver genetic material to the body that makes human cells create a protein from the virus.
This trains the immune system to be ready to attack if it encounters the novel coronavirus.
No mRNA vaccines have ever been approved for widespread use.
As well as proving highly effective in preventing Covid-19, both vaccines were found to be consistent across all age-groups -- a primary concern for a disease that hits the elderly the hardest -- as well as genders and ethnicities.
But there are important differences between the two.
Moderna’s vaccine can be kept in long-term storage at minus 20 degrees Celsius (minus four degrees Fahrenheit) while Pfizer’s requires minus 70 degrees Celsius (minus 94 degrees Fahrenheit).

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