What are the side effects of the Moderna and Pfizer COVID vaccines?

Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today		
	Darrell Etherington

		9 hours

Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today Darrell Etherington @etherington 9 hours

Global drugmakers Pfizer and BioNTech said on Wednesday that their COVID-19 vaccine was found 95% effective in the final analysis of the Phase 3 trial, including in people aged over 65 years, paving the way for the companies to apply for emergency authorisation from USA regulators within days.

"You know, the EUA (Emergency Use Authorization) may be approved in the middle of December or so", stated Moncef Slaoui, Operation Warp Speed chief. Conditional approval in the European Union could be secured in the second half of December, he added.

Of the 170 volunteers who contracted COVID-19 in Pfizer's trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95 percent effective.

The scientific head of the U.S. operation to develop a vaccine, Moncef Slaoui said Monday that the green light would probably come in December - a timeframe echoed by Sahin.

Dr. Peter Chin-Hong, an infectious disease specialist at UC San Francisco, said the symptoms typically appear in the first few hours after vaccination and resolve within 24 to 36 hours. Pfizer shares were up 1.6 percent while BioNTech jumped 3.8 percent in the United States.

"Our work to deliver a safe and effective vaccine has never been more urgent", Pfizer CEO Albert Bourla said in a statement.

The vaccine trial will continue to follow all participants for two more years in order to collect detailed safety data.

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A two-week quarantine would therefore leave less than a week until the planned start of the Australian Open on January 18. They are working [with] all of their partners and we're confident that we'll finish up with an Australian Open.

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, for December 8, 9 and 10, a source familiar with the process told CNN this week.

"Pfizer's partner BioNTech has announced that tomorrow they intend to file for emergency use authorization at the FDA", health secretary Alex Azar told a press conference Thursday in Washington.

Mike Ryan, the World Health Organization's top emergency expert, said it would be at least 4-6 months before significant levels of vaccination were taking place around the world.

Both the Pfizer/BioNTech and Moderna vaccines work using a new technology to trigger an immune response known as synthetic messenger RNA that can be produced at scale much more quickly than traditional vaccines. Pfizer, AstraZeneca and Moderna are among the front-runners in the global race to produce a vaccine to fight the infection. The most common adverse event rated as "severe" in the trial was fatigue, in 3.7 percent of participants after the second dose.

Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultra-cold temperatures of -70 degrees Celsius. In regular freezers they can be stored for only five days. Final results and safety data are expected in the coming days or weeks. Nine in 10 cases of severe illness were in the placebo group, another strong sign the vaccine protected against mild and serious cases.

"To go from identifying a new virus to having several vaccines at the point of applying for regulatory approval is an incredible milestone for science", she said. The Pfizer and BionTech vaccine went into tests shortly thereafter. The high initial efficacy rate observed with Pfizer and Moderna vaccines increases the likelihood that other vaccines targeting the spike protein will succeed.

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