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Pfizer announces 90% effective COVID vaccine - Memphis Local, Sports, Business News | Daily Memphian

Pfizer announced early Monday, Nov. 9, that its vaccine has shown to be a surprising 90% effective in preventing COVID-19.

“The results demonstrate that our mRNA-based vaccine can help prevent COVID-19 in the majority of people who receive it,” Pfizer Chairman and CEO Albert Bourla said. “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.”

He said Monday was a great day for science and humanity.

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Major markets around the world surged, including the S&P 500, which was up 3.7% after the opening bell. The Dow Jones Industrial Average was up more than 1,300 points.

By the third week in November, Pfizer expects it will have the final data required to apply to the FDA for emergency-use authorization.

“We are also generating data to show that our vaccine can be consistently manufactured to meet quality standards,” Bourla said in a statement. “Efficacy, safety and consistent manufacturing are the three requirements that are needed before we are able to file for authorization.”

Pfizer’s Phase 3 trial began July 27.

The study results came quicker than expected in part because so many people in the placebo group got COVID-19, said Dr. Stephen Threlkeld, co-director of the infectious disease program at Baptist Memorial Health Care.

“It’s possible when this is all said and done that we might look back at this as one of the red-letter days in overcoming this virus.

“It’s a very impressive result. We are talking about a vaccine, that if it holds up, is significantly better than the flu vaccine. The FDA said they were shooting for a greater than 50% efficacy, and we are talking about 90%,” he said.

Pfizer has been doing interim analysis on the positive cases among the nearly 44,000 people who have participated in its trials across six countries, including the United States.

There were 94 positive cases in the Pfizer study; more than 90% were among people who received the placebo, not the actual vaccine. The test hit that rate of effectiveness seven days after the second vaccine was administered, which means the trial showed protection 28 days after the first vaccine.

As the study continues, Pfizer said, the final vaccine efficacy percentage may vary.

“They were looking to get 164 cases,” Threlkeld said. “That was the hope in this trial. But obviously, when you get to enough cases to show a dramatic statistical significance, then it may be that will be enough for the FDA to (grant) an emergency-use authorization prior to what would have been the completion of the planned trial.”

The data is an interim analysis only and does not include findings on all the infections Pfizer is targeting.

“This is really good news from a couple of perspectives. Obviously, it’s great to have a vaccine candidate that works and it works really well,” said Dr. Jon McCullers, infectious disease expert and pediatrician-in-chief at Le Bonheur Children’s Hospital.

“Ninety percent is better than anyone would have expected, but it also tells us that a lot of other vaccine candidates might work as well because they’ve shown good immunogenicity (which means they generate strong immune response). The Pfizer vaccine has actually shown protection, and also offers immunogenicity.

“That could mean we may have lot of different vaccines to choose from,” he said.

Pfizer employs several hundred workers in Memphis at its offices at 949 S. Shady Grove.

“Anything above 50% would have been good enough,” said Dr. Manoj Jain, the infectious disease expert who has been advising the City of Memphis on its COVID response since March. “The flu vaccine is 40-50% effective.”

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Although Threlkeld said the results are extraordinary, there are still questions even with a vaccine with this level of efficacy.

“Number one, one of the important questions we have been asking a long time, how long will such a vaccine remain effective? And thankfully, that is actually built into this trial as well.

“There is a two-year endpoint where they are going to study the people who have received the vaccine over time to try to see the duration of the effectiveness. That will be another point we need to know. Do you need to repeat this vaccine every year? Does the effectiveness wane over eight months? Those things will be looked at over time.”

Even if emergency-use authorization is granted in November, it could be spring before the vaccine has been used broadly enough to “impact the way of life in our county,” Threlkeld said.

“It takes about a month to become immune once you get the vaccine.”

Pfizer, in conjunction with governments around the world, has been making huge quantities of the vaccine ahead of time. It projects it will have 50 million doses on hand by the end of the year and an estimated 1.3 billion vaccines in 2021, enough to give 650 million people two doses.

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Memphis is among the 120 sites where Pfizer is conducting trials. In early October, it said it hoped to recruit 500 people here. 

Susan Adler Thorp participated, saying even though her age makes her a member of a vulnerable population, she wanted to be part of the study.

“I did it because there comes a point in life, if you have the opportunity to do something really good, you ought to take it, even if there’s a risk. Nothing really good happens if people don’t take risks.

“I decided someone did the same thing for me at some point in history, whether it was polio, tetanus, whooping cough. Someone did it for me. I guess it was my turn to pass it on.”

It required one shot, a booster, intermittent blood tests and weekly check-ins, via an app, to report how she was feeling.

“It’s a blind study. You don’t know whether you got the vaccine or the placebo. I saw a very diverse group of people there.

“I felt very comfortable everything would turn out OK; I still do,” she said.

The Memphis trial was done with CNS Healthcare, 6401 Poplar. 

Regeneron Pharmaceuticals is also running a trial here in partnership with the University of Tennessee Health Science Center and Regional One Health. It is testing to see how well a cocktail of two synthetic antibodies performs against the virus, both in people recently diagnosed and those who live in close contact of someone who was a positive case.

Pharmaceutical companies go to lengths to recruit people from diverse backgrounds so they can see how the therapeutic works in different ethnicities and backgrounds, including people with chronic diseases.

Pfizer said about 42% of its global sample and 30% of its U.S. participants represent racially and ethnically diverse backgrounds.

The test data were reviewed by an independent data monitoring committee on Sunday, Nov. 8. 

The Pfizer vaccine requires two doses, about three weeks apart. It also requires a deep-freeze cold chain, which FedEx Corp. and other logistics companies have been working to create.

FedEx is ready to move vaccines once they’re released for distribution, FedEx Express president, The Americas, Richard W. Smith said on “60 Minutes” Sunday, Nov. 8.

Smith said he was confident in FedEx’s ability to deliver vaccines while dealing with the holiday peak shipping season on top of a e-commerce surge COVID-19 created back in March.

“We’re prepared to delivery to every ZIP Code in this country,” Smith said.

“I’d be crazy if I didn’t say this was a herculean effort and recognize how monumental it is and may yet be.”

FedEx has modified its facilities for ultra-cold storage to be able to handle the requirements of the Pfizer vaccine. The company operates a network of 90 cold chain facilities in the Americas, Europe, Asia and Australia, including one that opened in 2016 at the FedEx Express Memphis hub.

FedEx’s $25 million Cold Chain Centers around the world have been adapted to provide the ultra-cold storage needed for coronavirus vaccine. (Courtesy FedEx)

The cold chain network was built to hold shipments such as medicine, perishable foods and flowers in climate-controlled conditions, from room temperature down to minus 14 degrees Fahrenheit, which would cover common temperature ranges for most vaccines.

It wasn’t originally equipped with ultra-cold storage as low as minus 94 to minus 112 degrees Fahrenheit, the requirement for Pfizer’s vaccine. FedEx fixed that by buying super-freezers for the cold chain centers.

Pfizer is one of at least nine pharmaceutical companies working on vaccines that have reserved airlift from FedEx. Wall Street analysts have identified FedEx as a likely essential link in the vaccine supply chain by virtue of its cold chain capabilities and integrated global network. Vaccine shipments are expected to be worth billions to the shipping industry.

Although physicians say the news is phenomenal, there is no end yet to the isolation the world finds itself in now. And in the United States, it comes as the nation prepares for markedly quieter Thanksgiving. Cases and hospitalizations here are close to the highest they have been since the pandemic began.

“Hope is crucial,” Threlkeld said. “We’ve been sort of quagmired in this, forever isolating, forever masking, forever social distancing. It depresses people and also unfortunately, makes them less vigilant over time.

“Hope goes a long way when you know that might be the hope of an endpoint where things will be better. I think it certainly energizes both people taking care of folks who are sick with this, and it also can energize the people out there to prevent them from getting sick by doing the things we know we need to do."

Source - https://dailymemphian.com/section/business/article/17984/fedex-to-deliver-pfizer-vaccine-effective-against-covid-19

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