POST 64. November 10, 2020. CORONAVIRUS. “It works! Scientists have greeted with cautious optimism a press release declaring positive interim results from a coronavirus vaccine phase III trial — the first to report on the final round of human testing.”
“New York City-based drug company Pfizer made the announcement on 9 November. It offers the first compelling evidence that a vaccine can prevent COVID-19 — and bodes well for other COVID-19 vaccines in development. But the information released at this early stage does not answer key questions that will determine whether the Pfizer vaccine, and others like it, can prevent the most severe cases or quell the coronavirus pandemic.
“We need to see the data in the end, but that still doesn’t dampen my enthusiasm. This is fantastic,” says Florian Krammer, a virologist at Icahn School of Medicine at Mount Sinai in New York City, who is one of the trial’s more than 40,000 participants. “I hope I’m not in the placebo group.”
The vaccine, which is being co-developed by BioNTech in Mainz, Germany, consists of molecular instructions — in the form of messenger RNA — for human cells to make the coronavirus spike protein, the immune system’s key target for this type of virus. The two-dose vaccine showed promise in animal studies and early-stage clinical trials. But the only way to know whether the vaccine works is to give it to a large number of people and then follow them over weeks or months to see whether they become infected and symptomatic. These results are compared with those for a group of participants who are given a placebo.”(A)
“A preliminary analysis of the race frontrunner, Pfizer-BioNTech’s mRNA vaccine, suggested it was 90% effective in preventing symptomatic Covid disease. While these are early findings — the trial is still ongoing — they suggest the vaccine could be very protective.
There’s another important caveat. We don’t yet have details about whether the vaccine blocked mainly mild cases, or if there is evidence that it seemed to prevent some severe infections, too.
Still, the early results are encouraging for the Pfizer-BioNTech partnership. But embedded in the announcement is broader good news for Covid-19 vaccine development. Here are four reasons for encouragement based on the early results, starting with the most important.
We are likely to have multiple successful Covid-19 vaccines.
The Pfizer vaccine targets the spike protein, the knobby protrusion on the SARS-CoV-2 virus that allows the virus to attach to and invade human cells, initiating infection.
In fact, all of the vaccines being developed by major manufacturers working with Operation Warp Speed, the U.S. government effort to fast-track vaccines, target the spike protein.
There have been at least theoretical concerns that this was the vaccine development equivalent of putting all our eggs in one basket. The interim Pfizer data suggests the basket is the right one.
“There was always a discussion: Is the spike protein the right target? Well, now we know it’s the right target,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told STAT on Monday. “So, it’s not only immediate good news, it really is optimistic about what’s going to roll out in the next several months with the other vaccines.”
That forecast applies globally. All the vaccines being developed with the help of the Coalition for Epidemic Preparedness Innovations — which has been funding research and production with the aim of producing vaccine for worldwide distribution — target the spike protein.
“We believe these interim results also increase the probability of success of other Covid-19 candidate vaccines which use a similar approach,” CEPI CEO Richard Hatchett said in a statement.” (B)
“The news — the first results from any late-stage vaccine trial — buoyed stock markets and spirits as the public saw a glimmer of hope. But it’s worth noting that the news is still preliminary, and there is much that is still not known about how well the vaccine works.
And one thing remained clear: The vaccine will not come in time to rescue the world from the next several months, when the virus will take many more lives unless the public takes more stringent public health measures.
Here’s what we know, and don’t know, about the vaccine.
What did these scientists find out?
Is that a good result?
Is the Pfizer vaccine safe?
Who will get the new vaccine first?
When will the general public be able to get it?
What is left to do in the trial?
Will it work on older people?
The new results also don’t tell us whether older people will get strong protection from the vaccine.
What about children? (C)
“It’s said that success has many authors, and the encouraging data from Pfizer Inc.’s experimental Covid-19 vaccine had plenty of people in Washington lining up to take credit.
Vice President Mike Pence was among Trump administration officials saying support from the government’s Operation Warp Speed program helped accelerate the development of the vaccine, which was found to be more than 90% effective in preventing symptomatic Covid-19 infections in an interim analysis.
The truth is that Pfizer didn’t receive any funding from Operation Warp Speed for the development, clinical trial and manufacturing of the vaccine. Rather, its partner, BioNTech SE, has received money — from the German government.
BioNTech is credited for contributing the messenger RNA technology, which prompts the body to make a key protein from the virus, creating an immune response. The biotechnology company already had a history of working with Pfizer on influenza vaccines, and in March they clinched a deal to co-develop a shot to prevent against Covid-19 at research sites both in the U.S. and Germany. The two companies began human testing of the vaccine in April, before the existence of Operation Warp Speed was revealed publicly.
Berlin gave the German company $445 million in an agreement in September to help accelerate the vaccine by building out manufacturing and development capacity in its home market.
What the U.S. did, meanwhile, was commit to buying hundreds of millions of vaccines in advance to ensure Americans were among the first in line if it clinches an emergency-use authorization or approval from the FDA. The Trump administration agreed in July to pay almost $2 billion for 100 million doses, with an option to acquire as many as 500 million more, once that clearance comes.
As part of that agreement, the U.S. gets to decide who gets the vaccine first, and will work with the company on logistical support. While most vaccine front-runners that have been tapped by Warp Speed will distribute their doses through a government partnership with McKesson Corp., Pfizer is handling its own delivery of its products. The company has designed reusable containers that can keep the doses at ultracold temperatures, and is organizing trucks and flights to move them.” (D)
(A)What Pfizer’s landmark COVID vaccine results mean for the pandemic, by Ewen Callaway, https://www.nature.com/articles/d41586-020-03166-8
(B)Four reasons for encouragement based on Pfizer’s Covid-19 vaccine results, By HELEN BRANSWELL, https://www.statnews.com/2020/11/09/four-reasons-for-encouragement-based-on-pfizers-covid-19-vaccine-results/
(C) Pfizer’s Covid Vaccine: 11 Things You Need to Know, By Carl Zimmer and Katie Thomas, https://www.nytimes.com/live/2020/pfizer-covid-19-vaccine?referringSource=articleShare
(D) Pfizer Vaccine’s Funding Came From Berlin, Not Washington, By Riley Griffin and Drew Armstrong, https://www.bloomberg.com/news/articles/2020-11-09/pfizer-vaccine-s-funding-came-from-berlin-not-washington
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