DM Monitoring
WASHINGTON: Final results from Pfizer Inc’s COVID-19 vaccine trial showed its shot had a 95% success rate and two months of safety data, paving the way for the drug maker to apply for an emergency US authorization within days, it said on Wednesday.
The vaccine’s efficacy rate, the highest of any candidate in late-stage clinical trials so far, was welcomed by experts who had already said that interim results showing Pfizer’s shot was over 90% effective were very encouraging. Pfizer said there were 170 cases of COVID-19 in its trial of more than 43,000 volunteers and only eight people with the disease had been given the shot rather than a placebo, meaning the vaccine had a 95% efficacy rate. Of the 10 people who developed severe COVID-19, one had received the vaccine.
“The data is very strong,” said Ian Jones, a professor of virology at Britain’s University of Reading. “It’s looking like a real contender.”
Pfizer said it expected the U.S. 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. “We continue to move at the speed of science, and we know that every day matters in our path to authorization,” Pfizer Chief Executive Albert Bourla said.
The final analysis comes just a week after initial results from the trial showed the vaccine, developed with German partner BioNTech SE, was more than 90% effective. Moderna Inc on Monday released preliminary data for its vaccine, showing 94.5% effectiveness. 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.
However, while some groups such as healthcare workers will be prioritized in the United States for vaccinations this year, it will be months before large-scale rollouts begin.
Distribution of a Pfizer shot is complicated by the need to store it at ultra-cold temperatures of -70 degrees Celsius. It can, however, be kept in a normal fridge for up to five days, or up to 15 days in a thermal shipping box. Pfizer said the efficacy of the vaccine was consistent across different age and ethnic groups, a sign that the immunization could be employed broadly around the world. Efficacy in adults over 65 years, who are at particular risk from the virus, was over 94%.
“The 94% 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.
Equity markets strengthened slightly on the Pfizer news. Europe’s STOXX 600 and the U.S S&P 500 futures both rose about 0.3% to hit highs for the day. The moves were small, however, compared with the jump when Pfizer first announced the vaccine was more than 90% effective on Nov. 9.
Pfizer shares rose 3% in premarket trade while BioNTech’s U.S.-listed shares jumped 8%. Pfizer said its two-dose vaccine, BNT162b2, was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly.
The only severe adverse event that affected more than 2% of those vaccinated was fatigue, which affected 3.7% of recipients after the second dose. Older adults tended to report fewer and milder adverse events.
