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REUTERS: Final results from Pfizer Inc’s COVID-19 vaccine trial showed its injection had a 95 percent success rate and two months of safety data, paving the way for the drugmaker to apply for an emergency clearance in United States in a few days, he said Wednesday.
The efficacy rate of the vaccine developed by Pfizer and its German partner BioNTech is the highest of any candidate in late-stage clinical trials so far, and experts said it was a significant achievement in the race to end the pandemic.
Pfizer said 170 volunteers in its trial involving more than 43,000 people contracted COVID-19, but 162 of them had only received a placebo, meaning the vaccine was 95 percent 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, also based on a completely new technique,” said Enrico Bucci, a biologist at Temple University in Philadelphia “Today is a special day.”
Pfizer said it expected the US Food and Drug Administration’s Vaccine Advisory Committee to review and discuss the data at a public meeting likely to be held in December.
The final analysis comes one week after the initial trial results showed the vaccine to be more than 90% effective. Moderna Inc released preliminary data for its vaccine on Monday, showing an effectiveness of 94.5 percent.
The better-than-expected results of the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes of ending a pandemic that has killed more than 1.3 million people and wreaked havoc on the economies and daily life.
“These are extraordinary results, and the safety data looks good,” said David Spiegelhalter, professor and expert in risk communication and testing at the University of Cambridge.
“It would be interesting to see what adverse reactions the group that received the placebo reported, as that gives an idea of how many of the adverse effects are due to the vaccination process and how many are due to the vaccine itself.”
Global stocks rose on Wednesday as Pfizer’s trial results more than offset concerns about the stubbornly high global infection rate. Pfizer shares rose 2.9% when the US markets were opened, while BioNTech was up 4%.
MORE VULNERABLE
While some groups, such as healthcare workers, will have priority in the United States for vaccines this year, it will be months before large-scale deployments begin.
The dispensing of a Pfizer injection is complicated by the need to store it at extremely cold temperatures of -70 degrees Celsius. However, it can be kept in a regular refrigerator for up to five days, or up to 15 days in an insulated shipping box.
Moderna’s vaccine can be stored for up to six months at -20 ° C, although it is expected to be stable for 30 days at normal refrigerator temperatures of 2 to 8 degrees Celsius (36 ° -46 ° F).
Pfizer said the vaccine’s effectiveness was consistent across different ethnic and age groups, a sign that immunization could be widely used around the world. The efficacy in adults older than 65 years was more than 94 percent.
“The 94 percent protection for the elderly is key. This is the evidence we needed to make sure the most vulnerable people are protected,” said Andrew Hill, visiting principal investigator from the department of pharmacology at the University of Liverpool.
Pfizer said its two-dose vaccine, BNT162b2, was well tolerated and that the side effects were mostly mild to moderate and disappeared quickly.
He said the only serious adverse events experienced by the volunteers were fatigue and headaches. Of the 8,000 participants, 2% had headaches after the second dose, while 3.8% experienced fatigue. Older adults tended to report fewer and milder adverse events.
For her trial, Moderna named five serious side effects experienced by at least 2 percent of those who received her injection: fatigue at 9.7 percent, muscle pain at 8.9 percent, joint pain at 5.2. percent, headache at 4.5 percent, pain at 4.1 percent, and redness around the injection site at 2 percent.
MILLION DOSES
Pfizer’s bottom line comes as the virus spreads rampant around the world, putting enormous pressure on healthcare systems with a record number of new cases and hospitalizations.
The arrival of winter in the Northern Hemisphere along with the Christmas season is expected to worsen the number of cases as people spend more time indoors and have family gatherings.
“With hundreds of thousands of people around the world infected every day, we urgently need to bring a safe and effective vaccine to the world,” said Pfizer CEO Albert Bourla.
Pfizer and BioNTech also said they plan to submit the data to other regulatory agencies around the world and submit the study data to a peer-reviewed scientific journal.
Pfizer reiterated that it expects to produce up to 50 million doses of vaccines this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
Of the dozens of drug manufacturers and research groups competing to develop COVID-19 vaccines, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to release data this year.
GRAPHIC: Vaccine Race Tracking: https://tmsnrt.rs/3nEc4Gz
(Reporting by Michael Erman in Maplewood, NJ; additional reporting by Ankur Banerjee in Bengaluru, Caroline Humer in New York, Elizabeth Howcroft and Kate Kelland in London, and Emilio Parodi in Milan; written by David Clarke; edited by Edwina Gibbs and Pravin Char )
