Solving COVID: July 8, 2020

1. Pfizer's coronavirus vaccine candidate is 'viable'

The first clinical data on a vaccine candidate produced by pharmaceutical giant Pfizer in partnership with German biotech firm BioNTech showed some positive results, although there were side effects, Stat News reports. The study randomly assigned 45 patients one of three doses of the vaccine or a placebo. The bad news is half of the patients who received the highest dose of the vaccine developed fevers, so they weren't given a second injection. But those who received the two lower doses did receive a second dose. The vaccine generated neutralizing antibodies that prevent the coronavirus from functioning, and the levels of those neutralizing antibodies were 1.8 to 2.8 times higher than the levels found in recovered COVID-19 patients. More than 50 percent of the volunteers reported some kind of adverse side effect, but none were considered life-threatening or resulted in hospitalization or disability. No one knows if antibodies lead to immunity, and Pfizer will have to conduct larger studies to figure that out, but the findings represent a promising first step.

Stat News

2. Newly approved COVID-19 test promises results in 15 minutes for about $20

The Food and Drug Administration has granted emergency use approval for Becton Dickinson's COVID-19 antigen test. The test can be used by people with little laboratory training on a portable device about the size of a smartphone that returns results within 15 minutes, Becton Dickinson said in a statement. The tests can be run on the company's Veritor Plus System, which is already in use at about 25,000 U.S. health-care facilities, at a cost of about $20 per test, not counting the $250 to $300 price for the platform itself. Becton Dickinson suggested its test could be used in retail pharmacies, urgent care clinics, and doctor's offices, and set a goal of producing 2 million tests a week by the end of September. The FDA approved the test only for specific facilities, not home use, but chief executive Tom Polen said, "people keep saying 'For that, I want to buy one for my house.'"

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Becton Dickinson Bloomberg

3. Drugmaker says it could have potential coronavirus treatment ready by end of summer

Regeneron Pharmaceuticals will have a head start on distribution of its COVID-19 drug cocktail should the Food and Drug Administration grant the treatment emergency use authorization. The U.S. government has signed a $450 million dollar contract with the company to make and supply the cocktail — which consists of two human antibodies binding "non-competitively to the receptor binding domain of the virus' spike protein" hindering its ability "to escape treatment." Pending FDA approval, Regeneron said it expects somewhere between 70,000 and 300,000 treatment doses or 420,000 to 1.3 million prevention doses, with the initial batch ready to go as early as the end of this summer. If that's the case, the government has reportedly committed to making the doses available to Americans at no cost and would be responsible for their distribution.

CNBC

4. Coronavirus vaccine testers see fertile grounds in Texas, Florida, and Arizona

The U.S. government is planning to fund three 30,000-subject phase 3 COVID-19 vaccine trials starting this month, and Pfizer is recruiting for its own similarly large vaccine trial. Lining up volunteers for such trials can be challenging: "They need to be in an area where the virus is currently spreading, otherwise you learn nothing about the effectiveness of the vaccine," National Institutes of Health Director Francis Collins explains to The Wall Street Journal. That means COVID-19 hotspots like Florida, Arizona, and Texas are seen as fertile ground for recruiting. There are about 150 COVID-19 vaccines under development, and the need to quickly procure qualified volunteers has effectively created competition between the trials. Vaccine developers and recruitment organizations are using novel techniques to find volunteers, including working with churches and community groups, trawling testing centers and pharmacies, using algorithms, and asking employees to reach out to friends and family.

The Wall Street Journal

5. U.S. to pay Novavax $1.6 billion to fast-track vaccine development

The federal government is paying drug maker Novavax $1.6 billion to speed up its effort to develop a coronavirus vaccine. The commitment to Novavax, a Maryland company that has yet to bring a product to market, is the biggest yet under a government coronavirus vaccine and treatment push dubbed Operation Warp Speed. The money will be paid to Novavax to produce 100 million doses of the vaccine by the start of 2021, provided the vaccine clears clinical trials. rials. The deal brings the federal government's investment in companies working on COVID-19 vaccines to $4 billion. British drugmaker AstraZeneca got $1.2 billion to help it develop its vaccine, and Moderna Therapeutics, another company that has never brought a product to market, has received more than $500 million. "We are grateful to the U.S. government for its confidence in our technology platform," Novavax CEO Stanley C. Erck said.

The New York Times