Pfizer’s COVID vaccine appears promising, however massive hurdles stay

Pfizer's COVID vaccine looks promising, but big hurdles remain

(HealthDay) – The results of the early COVID-19 vaccine study that Pfizer announced this week raised hopes for a speedy end to the pandemic that killed more than 242,000 people and infected more than 10 million in the US alone.

But even if the preliminary results released on Monday are released, it will be many months before enough vaccine is made to vaccinate everyone in the US, experts warn.

The healthcare industry will also face unique sales challenges associated with this particular vaccine, which must be stored extremely cold and dispensed on a two-shot regime.

"People should be excited, but they should be aware that the benefits we will get from this vaccine will not be in winter, but not in the short-range. in spring through summer 2021, "said Dr. Amesh Adalja, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore.

"It shouldn't change your approach to the virus today, tomorrow, next week, next month," he added. "We are entering a time of year when the spread across the country is accelerating. We need to be very vigilant. The cases are reaching the point where they are flooding hospitals in some states. The course of the virus right now sees it for." the winter looks very bad. "

Adalja's words coincide with President-elect Joe Biden, who praised the news of Pfizer's vaccine success but urged Americans to remain vigilant.

"America is still losing over 1,000 people a day to COVID-19, and that number is increasing – and will continue to get worse if we don't make progress on masking and other emergency measures," Biden said Monday. "That is the reality for now and for the next few months. Today's announcement promises a chance to change that next year, but the tasks ahead now remain the same."

"No Serious Security Concerns"

Pfizer's early information – more than 90% effective – is extremely encouraging, said Dr. Thad Stappenbeck, director of the Lerner Research Institute at Cleveland Clinic in Ohio.

"If you get the vaccine, based on the early statistics, if you encounter the virus, you have a 90% chance of not being infected, which is remarkable," Stappenbeck said. Pfizer had set a goal of 50% effectiveness for its vaccine – the average effectiveness of its annual flu shot.

Of more than 43,500 people who received either the vaccine or a placebo, there were 94 confirmed cases of COVID-19, Pfizer said in its early analysis.

"Almost all new infections were in the placebo group," said Stappenbeck.

Pfizer will have to spend a few more weeks collecting safety data before applying for an emergency permit with the U.S. Food and Drug Administration. However, Stappenbeck expressed confidence that the vaccine will prove safe.

"They have now moved from just a few dozen people or a few hundred people to tens of thousands of people, and there are no serious safety concerns," he said.

Pfizer plans to produce up to 50 million doses of the vaccine by the end of the year – enough to vaccinate 25 million people – and up to 1.3 billion doses by 2021.

According to the New York Times, Pfizer makes the vaccine at facilities in Kalamazoo, Michigan and Puurs, Belgium. Cans distributed in the US are mainly from Kalamazoo.

The US government has placed an initial order for 100 million doses of the vaccine, priced at $ 1.95 billion, with an option to purchase an additional 500 million doses, Politico reports.

"There's a goal of 660 million doses, so there are two doses for anyone in the US who wants one," said Anna Legreid Dopp, senior director, clinical guidelines and quality improvement for the American Society of Health System Pharmacists (ASHP). in Bethesda, Md.

Who comes first?

The early doses will likely be given to health care workers and first responders, Dopp said, followed by people at high risk of serious COVID-19 infections.

However, distributing the doses across the country is expected to be a challenge in itself.

The vaccine must be stored at around minus 94 degrees Fahrenheit, which is about as cold as it gets on a winter day at the South Pole. The shot can withstand normal refrigeration only about 24 hours and a room temperature of no more than two hours after thawing, reports Politico.

Creating a "cold chain" of distribution that keeps the vaccine frozen until it is time for a person to be shot "is absolutely going to be an added burden," Adalja said.

"This doesn't just have to be kept at normal refrigerator temperatures. It has to be kept at minus 70, minus 80 degrees Celsius, which most places can't, no matter where you are in the US, let alone the developing world," Adalja said.

These type of freezers are common in academic centers and could even be found in community hospitals, Stappenbeck said.

"These aren't very expensive. They cost $ 5,000 or $ 6,000," he added.

According to the New York Times, major shipping companies United Parcel Service (UPS) and FedEx are trying to set up freeze farms in the country's major hubs. Aircraft and trucks also need to be equipped with freezers.

According to Dopp, further innovations are in the works, for example "thermal cases that allow a certain flexibility if you do not have access to a freezer".

Two-dose regimen

The other distribution problem that needs to be addressed is timing: people need to get the vaccine in two doses, about a month apart, Dopp said.

Hospitals, doctors and pharmacies need to set up computer systems to track patients and make sure they get their second dose on time, Dopp said. Otherwise, they won't get full protection from the vaccine, and possibly none at all.

Another problem, 10 more COVID-19 vaccine candidates are in the final testing phase, noted Dopp. Once approved, doctors need to keep track of which patients received which vaccine.

"A patient cannot have one vaccine for their first dose and another vaccine from a different manufacturer for their second dose," she said.

ASHP feared that if hospitals started distributing the first shots they would have to keep at least half of their original allocations in reserve so people could get their second shot on time.

"The response we got from the US Centers for Disease Control and Prevention is that they are not working to provide just-in-time duplicate doses, which I think is encouraging as it allows more people to use it their can begin series, "said Dopp.

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Pfizer's COVID Vaccine Looks Promising, But Big Hurdles Remain (2020, Nov 12)
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