The Gazette Today

IT'S WORTH DAILY

Pfizer Covid-19 vaccine is 90% effective.

6 min read
Pfizer Inc said on Monday its experimental COVID-19 vaccine was more than 90% effective, a major victory in the fight against a pandemic that has killed more than a million people, battered the world's economy and upended daily life.

Pfizer Inc said on Monday its experimental COVID-19 vaccine was more than 90% effective, a major victory in the fight against a pandemic that has killed more than a million people, battered the world’s economy and upended daily life.

Pfizer and German partner BioNTech SE are the first drugmakers to release successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have so far found no serious safety concerns and expect to seek US authorization this month for emergency use of the vaccine.

  • Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
  • Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
  • Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
  • Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
  • Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints

What do the early Pfizer Covid-19 vaccine results say?

The company’s first interim efficacy analysis signals that the vaccine is able to demonstrate an effectiveness against Covid-19. According to the findings, the vaccine was “more than” 90 per cent effective in preventing Covid-19 among vaccinated participants who had never contracted the contagious infection on the seventh day after they had received the second dose. This was in comparison to participants who had only received a placebo.

Considering that the USFDA as well as several international regulators and health organisations have suggested that a Covid-19 vaccine has to be able to protect at least 50 per cent of those receiving it, the findings in Pfizer and BioNTech’s case seem promising.

“The results demonstrate that our mRNA-based vaccine can help prevent COVID-19 in the majority of people who receive it. This means we are one step closer to potentially providing people around the world with a much-needed breakthrough to help bring an end to this global pandemic,” said Albert Bourla, CEO, Pfizer, in a statement upon the release of the results.

“This is a first but critical step as we continue our work to deliver a safe and effective vaccine,” he added.

The phase 3 trials of this vaccine candidate–BNT162b2–began on July 27 and has so far enrolled 43,538 participants, 38,955 of whom had received a second dose as of November 8.

He further added “It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.”

If Pfizer’s vaccine is authorized, the number of doses will initially be limited.

Pfizer Inc said on Monday its experimental COVID-19 vaccine was more than 90% effective, a major victory in the fight against a pandemic that has killed more than a million people, battered the world’s economy and upended daily life.

Pfizer and German partner BioNTech SE are the first drugmakers to release successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have so far found no serious safety concerns and expect to seek US authorization this month for emergency use of the vaccine.

Health experts said Pfizer’s results were positive for all COVID-19 vaccines currently in development since they show the shots are going after the right target and are a proof of concept that the disease can be halted with vaccination.

“Today is a great day for science and humanity,” Albert Bourla, Pfizer’s chairman and chief executive, said.

“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 nearing over-capacity and economies struggling to reopen.”

If Pfizer’s vaccine is authorized, the number of doses will initially be limited and many questions remain, including how long the vaccine will provide protection.

BioNTech Chief Executive Ugur Sahin told Reuters he was optimistic the immunisation effect of the vaccine would last for a year although that was not certain yet.

“This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general,” said Peter Horby, professor of emerging infectious diseases at the University of Oxford.

MARKETS SURGE

The prospect of a vaccine electrified world markets with S&P 500 futures hitting a record high and tourism and travel shares surging. Shares of companies that have benefited from pandemic-related lockdowns dropped including conferencing platform Zoom Video Communications which was down 12% in premarket trading.

Pfizer shares were indicated 14.2% higher in pre-market trading in New York, while BioNTech’s stock was up nearly 23% in Frankfurt.

“Light at the end of the tunnel. Let’s just hope the vaccine deniers won’t get in the way, but 2021 just got a lot brighter,” said Neil Wilson, chief market analyst at Markets.com

Shares of other vaccine developers in the final stage of testing also rose with Johnson & Johnson up 4% in pre-market trading and Moderna 7.4% stronger. Britain’s AstraZeneca was down 0.5%.

“The efficacy data are really impressive. This is better than most of us anticipated,” said William Schaffner, infectious diseases expert at Vanderbilt University School of Medicine, Nashville, Tennessee. “The study isn’t completed yet, but nonetheless the data look very solid.”

US President Donald Trump welcomed the test results, and the market boost: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” he said on Twitter.

President-elect Joe Biden said the news was excellent but did not change the fact that face masks, social distancing and other health measures would be needed well into next year.

1.3 BILLION DOSES

Pfizer expects to seek broad U.S. authorization for emergency use of the vaccine for people aged 16 to 85. To do so, it will need two months of safety data from about half the study’s 44,000 participants, which is expected late this month.

“I’m near ecstatic,” Bill Gruber, one of Pfizer’s top vaccine scientists, said in an interview. “This is a great day for public health and for the potential to get us all out of the circumstances we’re now in.”

Pfizer and BioNTech have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. They have also reached supply agreements with the European Union, the United Kingdom, Canada and Japan.

To save time, the companies began manufacturing the vaccine before they knew whether it would be effective. They now expect to produce up to 50 million doses, or enough to protect 25 million people this year.

Pfizer said it expects to produce up to 1.3 billion doses of the vaccine in 2021.

Leave a Reply

Your email address will not be published. Required fields are marked *