Successful Pfizer Vaccine Trial Indicates Advancement in Battle Against Pandemic

Pfizer Inc’s COVID-19 experimental vaccine is more than 90% effective based on initial test results, the drugmaker said Monday, a major victory in the war against a virus that has killed more than a million people and it has hit the world economy.

Scientists, public health officials and investors welcomed the first successful interim data from a large-scale clinical trial as a watershed moment that could help turn the tide of the pandemic if full test results are obtained. . However, the massive launches, which need regulatory approval, will not occur this year and various vaccines are seen as necessary to meet massive global needs.

Pfizer and German partner BioNTech SE said they had not yet encountered serious safety concerns and were hoping to apply for the US emergency use authorization this month, 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, noting that the data milestone comes with “infection rates setting new records, hospitals approaching excess capacity and economies struggling to reopen. “

Experts said they wanted to see the full trial data, but the preliminary results seemed encouraging.

“This news made me smile from ear to ear. It is a relief to see such positive results with this vaccine and it 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 the immunity can last.

“But the bottom line is, as a vaccine, it is more than 90% effective, which is extraordinary,” US leading infectious disease expert Dr. Anthony Fauci told CNN.

Pfizer hopes to apply for the US Emergency Use Authorization for persons ages 16 to 85. To do this, you will need two months of follow-up safety data to ensure no side effects occur. It is expected to be available in the third week of November.

US Secretary of Health and Human Services Alex Azar said it would take US regulators several weeks to receive and process the data before possible approval.

Increase in markets

The prospect of a vaccine electrified world markets with the S&P 500 and Dow hitting record highs. Shares in film and theme park company Walt Disney rose 12% and film chain operator AMC Entertainment Holdings rose 51%.

Shares of companies that have prospered during the lockdowns, such as Netflix Inc and the Zoom Video conferencing platform, fell. Arms stocks were sold due to increased hopes of a return to normalcy and a lack of civil unrest.

Pfizer shares rose more than 8% to their highest level since July last year, while BioNTech shares hit a record high.

Mizuho Securities analyst Vamil Divan predicted that the vaccine could generate sales in excess of $ 8.5 billion for Pfizer in 2020-2021 alone.

Shares of other vaccine developers in the final stage of testing also rose with Johnson & Johnson to nearly 4% and Moderna Inc, whose vaccine uses similar technology to Pfizer’s injection, to more than 8%. Britain’s AstraZeneca, however, fell 2%.

Moderna is expected to report the results of its large-scale test later this month. “We probably have more than one vaccine that is effective,” Fauci said.

William Schaffner, an infectious disease expert at Vanderbilt University School of Medicine in Nashville, Tennessee, rated Pfizer’s results as better than expected. “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: “THE STOCK MARKET IS RISING BIG, VACCINES SOON. REPORT 90% EFFECTIVE. SO GOOD NEWS! “he 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 called the results very positive, but warned that there was a funding gap of $ 4.5 billion that could slow access to tests, drugs and vaccines in low- and middle-income countries.

There are also other challenges that could affect less wealthy countries. Pfizer vaccine must be shipped and stored at extremely cold temperatures, which requires the necessary infrastructure. Even many US hospitals lack these super cold storage units, which can affect when and where the vaccine will be available in many rural US areas as well.

That highlights the need for more traditional vaccines in development, like the J&J candidate.

‘Almost ecstatic’

Still, there was cause for jubilation.

“I’m almost ecstatic,” said Bill Gruber, one of Pfizer’s top vaccine scientists, 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.

The interim analysis, performed after 94 trial participants developed COVID-19, examined how many had received the vaccine versus a placebo.

Pfizer did not provide that detail, but an effectiveness greater than 90% implies that no more than 8 of the 94 had received the vaccine, given in two injections approximately 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.

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 it could be before the end of November.

Lawrence Young, professor of molecular oncology at Britain’s University of Warwick, noted that the data may show that the vaccine prevents people from getting sick, but not necessarily from becoming infected. “And the nice thing … is that if you are infected, you can still transmit the virus.”

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.

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