- The Washington Times - Monday, November 23, 2020

A coronavirus vaccine from AstraZeneca was “highly effective” and staved off severe disease in an early look at trial data from the U.K. and Brazil, the company said Monday, signaling there could be a vaccine that’s easier to store than two versions nearing approval in the U.S.

The interim analysis showed an average efficacy of 70%, though one dosing strategy was up to 90% effective. Drugmakers are reporting vaccine progress at a dizzying pace as the coronavirus wreaks havoc across the Americas and Europe. Each candidate has its pluses and minuses.

A messenger-RNA version from Pfizer and German company BioNTech was 95% effective and is closest to getting into Americans’ arms. The New York company filed for emergency approval by the Food and Drug Administration last week.

Moderna, of Massachusetts, is close behind, its mRNA shots seem just as effective and can be stored in a refrigerator for up to 30 days compared to five days for Pfizer’s version, which must travel at deep-freeze temperatures in boxes packed with dry ice, making it the most complicated to handle.

AstraZeneca, meanwhile, said its shots will survive in the fridge for six months, offering an attractive option even if its efficacy rating wasn’t as eye-popping as its first-to-the-punch rivals.



Johnson & Johnson is close behind with a version that, unlike the others, requires only one dose, eliminating the need for a second visit to the doctor’s office or pharmacy.

Experts say it is good to have options as the nation looks to get enough doses in people to develop the type of herd immunity that can stamp out the pandemic.

“I think it’s important that we do have a menu of different vaccines because each may have issues with scaling up manufacture. The more vaccine doses that are out on the market, the better,” said Amesh Adalja, senior health scholar at the Johns Hopkins Center for Health Security. “There will likely be recommendations based on what is available in each country and each state for the general public. Each vaccine has its own features and logistical nuances. Thus far, all of them appear very promising.”

The world desperately needs relief. Discovered in Wuhan, China, in December 2019, the coronavirus is flaring again in Europe and the Americas and has killed more than 1.3 million people worldwide.

The seven-day rolling average of daily reported cases is at 171,000 — by far the highest of the pandemic — and over 1,500 Americans are dying from the disease each day, on average, adding to the world-leading death toll of nearly 257,000.

Nearly 84,000 people are hospitalized for COVID-19 in the U.S., which is more than double the number of hospitalizations a month ago and worse than the springtime crush in the Northeast or summer surge across the Sun Belt.

Health and Human Services Secretary Alex M. Azar II said the Trump administration is working to alleviate the strain on hospitals by dispatching thousands of doses of an “antibody cocktail” created by Regeneron Pharmaceuticals. The investigational drug was given to President Trump during his October bout with the virus, and the Food and Drug Administration approved the therapeutic for emergency use over the weekend.

The drug is designed to help patients with mild or moderate cases of COVID-19 avoid hospitalization.

“Distribution will begin tomorrow,” said Mr. Azar, who said the first tranche of 30,000 doses will be followed by many more in ensuing weeks.

On the vaccine front, Pfizer is the first drugmaker to request emergency-use authorization, or EUA, from the FDA.

The agency will review safety and efficacy data from the company, which stunned the world with its 95% efficacy rate in phase 3 trials. FDA officials are scheduled to meet Dec. 10 to discuss Pfizer’s application with an advisory board, which will make recommendations on approval.

Moderna is expected to request EUA from the FDA in the coming days or weeks, setting the stage for a similar meeting with the outside panel.

“Without question, any new vaccine must meet the FDA’s rigorous standards for quality, safety and efficacy and will be verified in consultation with the independent experts of the vaccine advisory committees, which previously advised FDA on preventive vaccines for pneumonia, HPV, and hepatitis,” said White House spokesman Michael Bars.

Pfizer and Moderna both used a messenger-RNA platform that is new and daring but appears to be paying off. The challenge is that both shots require cold storage temperatures — especially Pfizer’s, which must be maintained at minus-95 degrees Fahrenheit in ultralow freezers or packed in dry ice that must be replenished after 10 days or if the shipping boxes are opened, for 15 days of extra storage.

Some experts say they expect rural areas to gravitate toward the Moderna vaccine, given its longer shelf life and the fact Pfizer’s vaccines are packed in shipments of at least 975 vaccines, so far-flung areas might not be able to use them up in time.

“The way I like to put it is Pfizer’s vaccine is a vaccine where you have to bring the people to the vaccine,” said William Schaffner, an infectious-diseases expert at Vanderbilt University. “On the other hand, Moderna’s vaccine is pretty much like a usual vaccine. In that one, you can bring the vaccine to the people.”

The administration said Monday it is exploring options with parts of the shipping industry, such as UPS, to make sure extra doses that may expire are shuttled elsewhere in the country.

AstraZeneca’s vaccine uses an adenovirus — a weakened version of a common cold virus — and can last in the fridge for half a year, making it an attractive option for regular storage along vaccine distribution chains.

It is also cheaper, at $2.50 per dose, according to international agreements, compared to Pfizer’s $20 version and Moderna’s $15-$25, according to an Associated Press review of company agreements with the U.S. government.

The AstraZeneca version didn’t reach the eye-popping efficacy rating the messenger-RNA platforms did, but it exceeded the 50%-60% efficacy that government scientists predicted for COVID-19 vaccines.

The trial was separated into two dosing systems, one that was 90% effective and one that was 62%. One that involved just a half dose at first and full doses a month later achieved the higher rating, an intriguing finding that requires more study but does give scientists hope they can vaccinate more people in the near term.

“Excitingly, we’ve found that one of our dosing regimens may be around 90% effective, and if this dosing regime is used, more people could be vaccinated with planned vaccine supply,” Dr. Pollard said.

The company said it is preparing data to request emergency approval from regulatory agencies around the world. It will also work with the World Health Organization on a way to provide it to poorer countries.

“AstraZeneca made it very clear that we want to make our vaccine available for as many as possible people around the world,” Ruud Dobber, executive vice president for pharmaceuticals, told MSNBC. “So, that’s a big effort we are undertaking as we speak.”

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