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Rabu, 18 November 2020

Pfizer seeks clearance for COVID vaccine claiming 95 per cent effectiveness - ABC News

Pfizer says that more interim results from its ongoing coronavirus vaccine study suggest the shots are 95 per cent effective and that the vaccine protects older people most at risk of dying from COVID-19.

The announcement has arrived one week after Pfizer first revealed promising preliminary results and comes as the company is preparing to formally ask US regulators to allow emergency use of the vaccine.

Pfizer said 170 volunteers in its trial involving over 43,000 people contracted COVID-19 but 162 of them had only been given a placebo, meaning the vaccine was 95 per cent effective.

Of the 10 people who had severe COVID-19, one had received the vaccine.

"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," said Enrico Bucci, biologist at Temple University in Philadelphia.

Pfizer said it expected the US Food and Drug Administration's vaccine advisory committee to review and discuss the data in a public meeting that will likely be held in December.

"With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world," Pfizer Chief Executive Albert Bourla said.

Pfizer initially had estimated its vaccine, developed with German partner BioNTech, was more than 90 per cent effective after 94 infections had been counted.

Pfizer and BioNTech said they plan to submit the new data to other regulatory agencies around the world and submit data from the study to a peer-reviewed scientific journal.

"These are extraordinary results, and the safety data looks good," said David Spiegelhalter, a professor and expert in risk and evidence communication at the University of Cambridge.

"It would be interesting to see what adverse reactions were reported by the group getting the placebo, since that gives an idea of how much of the adverse effects are due to the vaccination process, and how much is due to the vaccine itself."

Highly effective for the elderly, mild side effects, Pfizer says

Earlier this week, Moderna announced that its experimental vaccine appears to be 94.5 per cent effective after an interim analysis of its late-stage study.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.

Pfizer said its vaccine was more than 94 per cent effective in adults over age 65, though it is not clear how the company determined effectiveness in older adults, with only eight infections in the vaccinated group to analyse and no breakdown provided of those people's ages.

"The 94 per cent protection for older people is key. This is the evidence we needed to ensure that the most vulnerable people are protected," said Andrew Hill, senior visiting research fellow at the University of Liverpool's department of pharmacology.

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

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

Out of 8,000 participants, 2 per cent had headaches after the second dose while 3.8 per cent experienced fatigue.

Pfizer says it now has the data on the vaccine's safety needed to seek emergency authorisation from the US Food and Drug Administration.

Up to 50 million doses to be produced in 2020

The study has enrolled nearly 44,000 people in the US and five other countries.

Pedestrians walk past Pfizer world headquarters in New York
Pfizer says it will seek emergency authorisation from the US Food and Drug Administration.(AP: Bebeto Matthews)

The trial will continue to collect safety and efficacy data on volunteers for two more years.

Pfizer and BioNTech said they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.

US officials have said they hope to have about 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December.

The first shots will be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.

Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca with the University of Oxford in November or December.

Johnson & Johnson says it is on track to deliver data this year.

AP/Reuters

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2020-11-18 13:23:00Z
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