What we still don’t know about COVID vaccines after the UK approved Pfizer-BioNTech candidate for emergency use


The UK government has authorized emergency use of the COVID-19 vaccine, developed by Pfizer Inc. and German BioNTech SE partner, with some fanfare on Wednesday, but experts warn that the news does not mean the pandemic is nearing its end.

The UK plans to start vaccinating front workers as early as next week, but many hurdles remain. The vaccine should be stored at minus 94 degrees Fahrenheit and transported to the UK from a facility in Belgium.

Matt Hancock, the UK Minister for Health, acknowledged that this would be a challenge but did not provide details on how to deal with it. Prime Minister Boris Johnson also acknowledged that we face a “huge logistical challenge”.

The initial dose is expected to contain about 800,000 doses, which is enough to vaccinate only half of people, as this is a two-dose treatment.


“The fact that this EU product is so good that Britain has approved it so quickly shows that European and international cooperation is the best in this crisis.”


– Jens Spahn, German Minister for Health

The UK’s National Health Service employs around 1.5 million people, according to the Nuffield Trust Health Brain Trust, making it the largest employer in the country and one of the largest employers worldwide. The total population of the UK is around 67 million.

Hancock suggested that rapid licensing be possible “because of Brexit”, the UK got rid of the perceived bureaucracy associated with the European Union, which is in the process of leaving.

But, as German Health Minister Jens Spahn pointed out, the vaccine was developed jointly by a German company, using European Union funds, and an American company.

“The fact that this EU product is so good that Britain has approved it so quickly shows that European and international cooperation is the best in this crisis,” Spahn told reporters in a briefing on Wednesday.

The vaccine itself is still in Phase 3 trials, and participants in such trials are expected to be monitored for several years. Vaccines usually take years to develop because they need a lot of safety data to ensure that they do not have harmful side effects.

See now: Dr. Atul Gawande at COVID-19: “It’s never too late to save another 100,000 lives”

The COVID-19 epidemic has mobilized pharmaceutical companies, biotechnologies and health agencies to act quickly to find vaccines and therapies and use new technologies to speed up the process. Pfizer and BioNTech PFE,
+ 3.52%

BNTX,
+ 6.21%
The vaccine was developed in a record ten months.

The Pfizer and BioNTech vaccines are messenger ribonucleic acids or mRNA vaccines that send a message to cells and urge them to create proteins that can elicit an immune response. Although we have high hopes for the technology, mRNA products have not been licensed in the U.S. for any indication.

See now:AstraZeneca COVID-19 vaccination data do not affect Wall Street analysts with clinical trial efficacy

Pfizer and BioNTech have not yet made the data from the late-stage study fully available to the public, but claimed that analysis of the early data showed that the vaccine appeared to be 95% effective and safe. However, the initial data were for only 170 adult volunteers in a study of almost 44,000 people, of whom only eight received the vaccine and the remaining 162 received the placebo.

None of the drug manufacturers without vaccine candidates in the works published clinical data on the performance of vaccines in peer-reviewed clinical trials in peer-reviewed medical journals, which is considered a gold standard when sharing medical research. So far, only temporary data points have been shared.

See now:BioNTech and Pfizer COVID-19 are surprisingly effective, although experts question how effective they will be in the real world

China and Russia have already introduced their own vaccines and have been criticized for doing so before the completion of Phase 3 investigations.

“Finally, even if a vaccination program should have started this month, the fact that two blows are needed means that it will probably take several months before we see the potential economic benefits of easing the restrictions, given that medical staff are likely to benefit first, along with more vulnerable people, and the entire population is at the end of the line, ”said Michael Hewson, an analyst at MC Markets.

This means that UK citizens, like people in other countries, must continue to follow the safety practices recommended by health experts – frequent hand washing, social separation and wearing face masks.

Nevertheless, Dr. Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia and co-inventor of the rotavirus vaccine, said the news was “reassuring.”

“Right now, everything we know comes from companies’ press releases. When regulators look at all the data, the ones that are below the tip of the iceberg, they come to the conclusion that this vaccine is what it seems to be reassuring, ”he said.

See: Paul Offit, Pediatrician, Philadelphia: Prepare to wear masks and social distance even after receiving COVID-19

The Pfizer – BioNTech vaccine candidate is one of three leading riders currently trying. Moderna Inc. MRNA,
+ 1.41%
It is also developing an mRNA vaccine and said it produced 94.5% efficacy in its late stages. Moderna is requesting US and EU emergency licenses for its candidate.

See also:COVID-19 vaccines should be designed for humans, not for profit

The third vaccine, developed by AstraZeneca PLC AZN,
+ 0.77%

AZN,
+ 1.75%
with the University of Oxford, a virus-vector-based vaccine, there were recent confounding results: the vaccine was 62% effective in the originally planned testing, while in volunteers, the manufacturing error was 90% effective compared to the reduced initial dose.

The U.S. Food and Drug Administration will meet on December 10 to review the Pfizer – BioNTech Vaccine Candidate and may issue an emergency license. Moncef Slaoui, head of the government’s “Operation Warp Speed” program to accelerate the development of a safe and effective vaccine, told ABC News that it expects the FDA to come to the same conclusion as its British counterpart.

See now:U.S. COVID-19 fatalities exceed 270,000 as CDC moves forward with plans to introduce expected vaccine

Shares of Pfizer rose 2.8% on Wednesday and have risen 9% this year to date. BioNTech’s U.S. custodian revenues grew 4.8% and in 2020 grew 253%. SPDR S&P Biotech ETF X,
+ 3.38%
increased by 39% over the same period, while the benchmark S&P 500 SPX,
+ 0.17%
It was 13% ahead.