Pfizer reports COVID-19 vaccine 95% effective as Phase 3 trial concludes

Joanna Estrada
November 21, 2020

Pfizer, an American company, and its German partner BioNTech said final results from the large Phase 3 study show the vaccine to be 95 percent effective against COVID-19. If people tested positive, they were logged as a confirmed COVID-19 case, and the researchers then looked at the group of COVID-19 cases and compared how many people had been vaccinated versus how many had gotten placebo.

"I don't find that time frame to be unreasonable in light of the amount of data the agency needs to analyze and in order to ensure full participation by all stakeholders in the advisory committee", said John Taylor, who served as counselor to the head of the FDA during the Obama administration and now works as a consultant at Greenleaf Health.

"While the mortality rates remain low, some experts worry that a rise in cases among children may mean a rise in cases of Multisystem Inflammatory Syndrome in Children (MIS-C) later", says USA Today.

More than 37,000 people have taken either the Pfizer or the Moderna vaccine in a Phase 3 trial.

Mr Hancock said the speed of the roll-out of a vaccine would depend on the speed it could be manufactured.

An FDA advisory committee tentatively plans to meet December 8-10 to discuss the vaccine, a source familiar with the situation told Reuters, though the dates could change. Azar's office did not respond to requests for comment.

On Wednesday, Pfizer announced its 44,000-person vaccine trial had hit the necessary endpoints for safety and efficacy and that it could file for emergency authorization within days.

There are a dozen coronavirus vaccine candidates in late-stage trials worldwide that use a variety of approaches, and no company could produce enough of one to protect the world's 7.8 billion people.

Earlier this month, Canada's Chief Public Health Officer said that when a coronavirus vaccine becomes available there will be a limited supply at first. Overall, the vaccine was shown to be 95% effective in preventing symptomatic Covid infection.

The news was especially welcome with the virus again running rampant around the world, setting records for new infections and hospitalizations nearly daily. Canada signed a deal with the company in August to secure 20 million doses of the vaccine in 2021. It also has agreements with the European Union, Germany and Japan where distribution could begin next year.

The Pfizer vaccine must be stored at about minus 80C, although it can be kept in a fridge for five days.

Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultra-cold temperatures of -70 degrees Celsius.

"We can expect both agencies to conduct a very careful evaluation and we can rely on their conclusions", he said. This, of course, will not be enough for everyone but it is expected several other successful vaccines will also be distributed over the coming year.

But they did notice headaches and fatigue in about 2% of volunteers given the vaccine, although older people seemed to experience minimal side effects.

Moderna, which worked with scientists from the National Institutes of Health, said Monday its vaccine was 94.5% effective against SARS-CoV-2 and the disease it causes, COVID-19. Johnson & Johnson said it is on track to deliver data this year.

How long does most vaccine development take?

High-priority populations such as healthcare workers and nursing home residents could obtain COVID-19 vaccines in December, Department of Health and Human Services Secretary Alex Azar said in a press conference.

Other reports by Click Lancashire

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