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EU launches a rolling review of the Pfizer-BioNTech coronavirus vaccine

A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida.

Eva Marie Uzcategui | Bloomberg | Getty Images

The European health regulator is reviewing a COVID-19 vaccine being developed by Pfizer and BioNTech in real-time, days after launching a similar assessment process for AstraZeneca’s vaccine.

The European Medicines Agency (EMA) said on Tuesday its human medicines committee was evaluating the first batch of data on the vaccine, and would continue to do so until enough data is available for a final decision. 

Pfizer and BioNTech said in a joint statement the start of the review is based on data from laboratory and animal testing, as well as early testing on humans, while continuing talks to submit data as it emerged.

The EMA is using “rolling reviews” to speed up evaluations of vaccines during the pandemic by studying data as it is submitted, rather than waiting for all data to be made available along with a formal application.

Last week, it began reviewing AstraZeneca and Oxford University’s vaccine, AZD1222 or ChAdOx1 nCoV-19, increasing chances of the British vaccine becoming the first to be approved in the region for the disease which has killed more than a million people globally.

While AZD1222 uses a weakened version of a chimpanzee common cold virus to build immunity against Covid-19, Pfizer and BioNTech’s vaccine, called BNT162b2, uses ribonucleic acid, a chemical messenger that contains instructions for making proteins.

When injected in people, BNT162b2 instructs cells to make proteins that mimic the outer surface of the novel coronavirus, which the body recognizes as a foreign invader and mounts an immune response against it.

Pfizer’s vaccine is currently being evaluated in late-stage studies in the United States, Brazil, South Africa and Argentina.

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EU agency starts ‘rolling review’ to speed OK for vaccine

LONDON (AP) — The European Medicines Agency has started a “rolling review” process for the COVID-19 vaccine being developed by Oxford University and AstraZeneca, a move it hopes will speed any eventual approval.

In a statement Thursday, the EU regulator said instead of waiting for all of the required vaccine data to be submitted before beginning its assessment, the EMA has begun analyzing the preliminary information from scientists on the Oxford vaccine.

That data suggests the vaccine “triggers the production of antibodies and T-Cells,” referring to immune system cells that target the virus. The agency said it was waiting for data from ongoing late-stage tests of the vaccine involving thousands of people, which it hopes will be shared in the coming weeks and months.

“The rolling review will continue until enough evidence is available to support a formal marketing authorization,” the EMA said.


The agency said it could not estimate how long this process might take, but that it would be quicker than the normal evaluation procedure. A similar process was used to issue an approval for remdesivir, one of the only licensed drugs to treat COVID-19. That approval was issued in just over one month while the standard process can take nearly seven months.

Oxford’s vaccine is designed to reduce disease and transmission. It uses a harmless virus — a chimpanzee cold virus, engineered so it can’t spread — to carry the coronavirus’ spike protein into the body, which should trigger an immune response. The tests are looking at both one-shot and two-shot vaccine doses.

Initial information suggested the vaccine provoked a strong immune response in volunteers and is safe, but longer-term data is needed.

AstraZeneca, which is manufacturing the vaccine, has signed numerous private deals to provide millions of doses to countries including Britain, the U.S., France, Germany and Canada. The first deliveries are expected this fall, before being licensed.

Last month, Britain’s trial of the Oxford vaccine was paused for several days after a U.K. woman in the trial reported severe neurological symptoms. Although the study has since restarted, a similar trial in the U.S. is awaiting further examination from the Food and Drug Administration before the research can continue.

Several other vaccines are undergoing late-stage testing in China, Russia, the U.S., Brazil and other hard-hit countries.

In August, Russia became the first country in the world to license its Sputnik V COVID-19 vaccine. The shot is still being tested in advanced trials but has been offered to key workers, several high-profile politicians and one of President Vladimir Putin’s daughters.

On Thursday, authorities in Belarus began testing Sputnik V in 100 volunteers in Minsk, the capital.

Several Chinese vaccine makers, including Sinovac Biotech Ltd, have also injected thousands of their employees and family members with their experimental shots, under an emergency use provision. The Chinese military has also approved the use of a vaccine it developed with CanSino Biologics Inc., a biopharmaceutical company, in military personnel.

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Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak

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