- The Washington Times - Monday, November 16, 2020

Moderna‘s coronavirus vaccine was nearly 95% effective and thwarted severe disease in an early look at the data, the company said Monday, putting a second drugmaker on track to request emergency approval from the government before the end of the year.

The news sparked cheers from a COVID-19-weary world, even rival drugmaker Pfizer, and notes of caution from leaders who say Americans must buckle down and avoid infection while the shots are approved and injected into arms through the middle of next year.

Moderna, of Cambridge, Massachusetts, said it counted 95 cases within its trial of 30,000 participants. Only five of them were in the group who got the vaccine, versus 90 in the placebo group.

Researchers also looked at 11 severe cases of COVID-19 and found that all of those participants received the dummy shots, not the vaccine. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said such a finding is “absolutely critical.”

“The results of this trial are truly striking,” said Dr. Fauci, whose institute collaborated with Moderna.



The news, which boosted fortunes on Wall Street, was announced one week after Pfizer said its coronavirus vaccine was over 90% effective in a preliminary analysis. Both companies are using a pioneering messenger-RNA platform for their vaccines.

“All the boxes have now been checked,” Dr. Fauci said. “The platform clearly works. It works here with Moderna, it worked with Pfizer.”

Although more analysis is needed, the early results stunned experts who had lower expectations for efficacy.

The world desperately needs a vaccine that can bring the coronavirus that causes COVID-19 to manageable levels next year. Discovered in Wuhan, China, in December, the virus spread around the globe. COVID-19 has killed more than 1.3 million people, including over 246,000 in the U.S.

The White House wants the Food and Drug Administration to act swiftly on emergency-use requests from companies so Operation Warp Speed can begin dispatching doses. In the meantime, federal and state officials are pleading with Americans to stay vigilant as the crisis worsens. The number of deaths is on the rise, and daily hospitalizations are near 70,000 — the most since the start of the pandemic.

New Jersey Gov. Phil Murphy, a Democrat, told residents to maintain physical distancing and mask-wearing protocols as COVID-19 metrics worsen in his state. Presumptive President-elect Joseph R. Biden echoed that message.

“Today’s news of a second vaccine is further reason to feel hopeful. What was true with the first vaccine remains true with the second: we are still months away. Until then, Americans need to continue to practice social-distancing and mask-wearing to get the virus under control,” Mr. Biden tweeted.

President Trump, meanwhile, focused on his administration’s feat as he faced a departure from the White House in January.

“For those great ‘historians,’ please remember that these great discoveries, which will end the China Plague, all took place on my watch!” the president tweeted before highlighting stock market gains.

Mr. Biden said the president needs to get the General Services Administration to begin the transition of power, including oversight of the vaccines.

“More people may die if we don’t coordinate,” Mr. Biden said. “What’s the game plan? It’s a huge, huge, huge undertaking.”

He said he would accept the vaccine if Dr. Fauci and other scientists say it is safe and that Mr. Trump made him leery earlier on.

“I wouldn’t hesitate to get the vaccine,” Mr. Biden said.

The U.S. government doled out $483 million to support Moderna‘s vaccine development. It also struck a $1.5 billion deal to support the manufacturing and delivery of doses.

Pfizer did not accept federal money for its research and development but did strike a $1.95 billion deal for the pre-purchase of doses, pending regulatory approval of the vaccine.

Moderna said a parallel study found its vaccine remains stable if stored at minus-4 degrees Fahrenheit for up to six months. Under normal refrigeration temperatures of 36 to 46 degrees, it can last for up to 30 days.

CEO Stephane Bancel said the company previously thought the vaccine could be refrigerated for only seven days.

That makes it easier to handle than Pfizer’s version, which is leading the race toward approval but must remain at minus-94 degrees if stored for months and can last five days in normal refrigeration. Pfizer made “thermal shippers” that can keep the vaccines stable for 10 days and for 15 additional days if the dry ice is replenished.

Though both companies are using m-RNA platforms, the storage temperature requirements are different because of the vaccines’ proprietary lipid coatings.

“Each of those lipid droplets is made different by the two companies, and the formulation is different. One of them, as we now know, is designed to have a greater temperature stability,” said Barry Bloom, a research professor and former dean of Harvard T.H. Chan School of Public Health.

Pfizer CEO Albert Bourla dismissed any sense of competition with a tweet saying he was “thrilled” with Moderna‘s results.

“Our companies share a common goal — defeating this dreaded disease — and today we congratulate everyone at Moderna and share in the joy of their encouraging results,” he tweeted.

The vaccination campaign could start before the end of the year, with enough doses for an estimated 20 million Americans in December and at least 25 million per month afterward, said Moncef Slaoui, who is leading the White House’s vaccine effort.

Health care workers will be immunized first, followed by other essential workers, the elderly and those with high-risk medical conditions. The general public should be able to get a vaccine by late March or April, according to federal timelines.

Officials said advisory groups will figure out which vaccines work best for specific populations or whether one vaccine is optimal for logistical reasons. Rural areas might find Moderna‘s refrigeration specifications more feasible.

Francis Collins, director of the National Institutes of Health, said the good news is that both products are promising.

“People who get offered one should feel quite happy about that,” he said.

Officials said they are aware that wide swaths of the public are skeptical of vaccines, especially given the record-breaking pace of development.

They hope the public will begin to trust the vaccines. Dr. Fauci stressed that administrators and participants in the trial did not know whether they were getting the vaccine or a placebo and that an independent safety monitoring board looked at the data. He said all of the clinical data will be made public.

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