Coronavirus vaccine’s two side-effects

 

Pfizer says it is "very close" to applying for an emergency use approval for its COVID-19 vaccine after collecting safety data to submit to US regulators.

"We are very close to submitting for an emergency use authorisation," Albert Bourla told medical news site Stat. "We will announce it as soon as we are doing it."

The FDA had imposed a requirement on COVID-19 vaccine makers of having at least two months of follow-up with volunteers after their second dose, taken 28 days after the first, in order to ensure the drugs are safe.

Pfizer CEO Albert Bourla said it "urgently" needed to "get a safe and effective vaccine to the world".

He said Pfizer would apply for emergency authorisation within days.

Enrico Bucci, a biologist at Temple University in Philadelphia. said: "Today is a special day."

"A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique," he said.

Pfizer says its vaccine, called BNT162b2, was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly.

The company said the only severe adverse events experienced by volunteers were fatigue and headaches.

Governments around the world have staked their hopes on a vaccine ending the coronavirus pandemic, eventually allowing economies to fully reopen and international travel to resume.

The Australian Government is also banking on a vaccine, with its economic forecasts underpinned by the assumption it will rolled out across the population by late next year.

Australia has secured 10 million doses of the two-dose Pfizer vaccine, which means about five million people would be covered.

On Monday, Moderna and the US National Institutes for Health announced similar preliminary results from their own trial, finding their vaccine was almost 95 per cent effective.

Both use mRNA (messenger ribonucleic acid) technology 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 SARS-CoV-2.

Other vaccines that are in late-stage trials, such as one being developed by Johnson & Johnson and another by Oxford University and AstraZeneca, use modified viruses to deliver genetic material for the same purpose.

No mRNA vaccines have ever been approved, but Anthony Fauci, the United States' top infectious disease scientist told AFP Tuesday the technology had now "established itself."

Mr Bourla told Stat he was relieved that another vaccine was also successful and hoped many more would enter the fray because the global need was so dire.

 

Pfizer announced further news about its vaccine on Wednesday morning US time, saying its phase three study has proved safe and they will submit data to a peer-reviewed journal.

"The study reached 170 confirmed cases of COVID-19, with the vaccine candidate BNT162b2 demonstrating 95% efficacy beginning 28 days after the first dose," the company said.

"To date, no serious safety concerns related to the vaccine candidate have been reported."

The company said it would submit a request to the US Food and Drug Administration within days "based on the totality of safety and efficacy data collected, as well as manufacturing data relating to the quality and consistency of the vaccine candidate."

"We also plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed."

"The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic," said Pfizer CEO Albert Bourla.

 

Originally published as Coronavirus vaccine's two side-effects



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