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By Michael Erman and Julie Steenhuysen
(Reuters) – Pfizer Inc
Experts welcomed the first successful interim data from a large-scale clinical trial as a watershed moment that showed vaccines could help stop the pandemic, although mass launches, which need regulatory approval, will not occur this year.
Pfizer and German partner BioNTech SE <22UAy.F> They said they had yet to find serious safety issues and were hoping to apply for U.S. authorization this month for emergency use of the vaccine, raising the possibility of a regulatory decision as early as December.
If granted, companies estimate they can distribute up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
“Today is a great day for science and humanity,” said Pfizer CEO Albert Bourla.
“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most, with infection rates setting new records, hospitals approaching overcapacity and economies struggling to reopen.” said.
Experts said they still wanted to see the full trial data, which has not yet been peer-reviewed or published in a medical journal, but the preliminary results looked encouraging.
“This news made me smile from ear to ear. It is a relief to see such positive results from this vaccine and bodes well for COVID-19 vaccines in general,” said Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford. .
There are still many questions, such as how effective the vaccine is by ethnicity or age, and how long it will provide immunity, with the “new normal” of social distancing and facial coverage remaining for the foreseeable future.
Pfizer hopes to obtain the US Emergency Use Authorization for persons ages 16 to 85. To do so, you will need two months of safety data from about half of the 44,000 study participants, which is expected in the third week of November.
US Secretary of Health and Human Services Alex Azar said US regulators would take several weeks to receive and process data on the vaccine before the government could approve it.
MARKET EMERGENCE
The prospect of a vaccine electrified global markets with the S&P 500 and Dow hitting record highs as stocks in banks, oil companies and travel companies soared. Actions at companies that have thrived during lockdowns, such as the Zoom Video conferencing platform
Pfizer shares rose more than 11% to their highest level since July last year, while BioNTech shares hit a record high.
Shares of other vaccine developers in the final stage of testing also increased with Johnson & Johnson
“The efficacy data is really impressive. This is better than most of us anticipate,” said William Schaffner, an infectious disease expert at Vanderbilt University School of Medicine in Nashville, Tennessee. “The study has not yet been completed, but the data looks very strong nonetheless.”
US President Donald Trump welcomed the test results and market momentum: “STOCK MARKET IN BIG, VACCINES COMING SOON. 90% EFFECTIVE REPORT. What GREAT NEWS!” tweeted.
President-elect Joe Biden said the news was great, but it didn’t change the fact that face masks, social distancing and other health measures would be needed until well into next year.
The World Health Organization said the results were very positive, but warned there was a $ 4.5 billion funding gap that could slow access to tests, drugs and vaccines in low- and middle-income countries.
‘ALMOST ECSTATE’
“I’m almost ecstatic,” Bill Gruber, one of Pfizer’s leading vaccine scientists, said in an interview. “This is a great day for public health and for the potential to lift us all out of the circumstances we are in now.”
Between 55% and 65% of the population will need to be vaccinated to break the dynamics of the spread of COVID-19, German Health Minister Jens Spahn said, adding that he did not expect a vaccine to be available before the first quarter. from 2021..
The European Union said on Monday it would soon sign a contract for up to 300 million doses of the Pfizer and BioNTech COVID-19 vaccine.
The companies have a $ 1.95 billion contract with the United States government to deliver 100 million doses of vaccines starting this year. They received no research funding from the Trump administration’s Operation Warp Speed vaccine program.
Pharmaceuticals have also reached supply agreements with the UK, Canada and Japan.
Pfizer said the interim analysis, conducted after 94 trial participants developed COVID-19, looked at how many had received the vaccine versus a placebo.
Pfizer did not break down how many of those who became ill received the vaccine. Still, more than 90% effective means that no more than 8 of the 94 received the vaccine, which was given in two injections three weeks apart.
The efficacy rate, which could drop once full results are available, is well above the 50% effectiveness required by the US Food and Drug Administration for a coronavirus vaccine.
Shortly after Pfizer’s announcement, Russia said its Sputnik V vaccine was also more than 90% effective, based on data collected from the vaccines from the public. Preliminary data from the phase III trial will be published this month.
MORE DATA IS NEEDED
To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 cases of COVID-19 among the volunteers. Bourla told CNBC on Monday that, based on rising infection rates, the test could be completed before the end of November.
Pfizer said its data would be peer-reviewed once it has the results of the entire test.
“These are interesting early signals, but again they are only reported in press releases,” said Marylyn Addo, director of tropical medicine at the Hamburg-Eppendorf University Medical Center in Germany.
Dozens of pharmacists and research groups around the world have been racing to develop vaccines against COVID-19, which surpassed 50 million cases on Sunday since the new coronavirus appeared late last year in China.
The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which is based on synthetic genes that can be generated and manufactured in weeks, and produced at scale faster than conventional vaccines. The technology is designed to trigger an immune response without using pathogens, such as actual virus particles.
The Trump administration has said it will have enough doses of vaccine for 330 million US residents who want it by mid-2021.
(Reported by Michael Erman and Julie Steenhuysen; Additional reporting by Michele Gershberg in New York, Ludwig Burger and Patricia Weiss in Frankfurt and Kate Kelland in London; Edited by Bill Berkrot, Caroline Humer, Edwina Gibbs and David Clarke)
