- The Washington Times - Monday, December 28, 2020

A fifth company on Monday started a late-stage trial of its coronavirus vaccine, as Maryland company Novavax reached phase 3 and potentially added to immunization options next year.

Novavax plans to enroll 30,000 participants at 115 sites in the U.S. and Mexico. The federal government is funding the trial.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the launch “demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines.”

Scientists want at least a quarter of enrollees to be 65 and older — a cohort that has been slammed by COVID-19 — and is emphasizing enrollment in communities of color.

The trial will be randomized, and two volunteers will receive the vaccine for every one who receives a placebo. It is blinded, so neither the researchers nor the participants know which type are in the injections, as a data-safety board monitors the trial from the outside.

A second injection will be delivered 21 days after the first.

President Trump’s vaccine initiative, Operation Warp Speed, supported three vaccine platforms for combating COVID-19, with two companies operating in each category. They wanted to hedge their bets and maximize production capacity by shepherding multiple drugmakers’ vaccines to approval and delivery.

The Novavax vaccine uses a “recombinant protein” technology. A partnership between Sanofi and GlaxoSmithKline uses a similar technology.

AstraZeneca and Johnson & Johnson are using an adenovirus platform and could seek approval in the first two months of the new year. The J&J version is intriguing because it requires only one dose and would speed up the immunization campaign as the virus surges across America, Europe and elsewhere.

Two “messenger RNA” vaccines, from Pfizer and Moderna, have been approved and are being used across the U.S.

Roughly 2 million people in the U.S. have been inoculated so far, according to a Centers for Disease Control and Prevention tracker.

There is a lag in data reporting from the states, so it’s likely that more people have received their initial dose.

It also takes time for states to receive the shots and get them into arms. Federal officials have acknowledged they might not meet their goal of getting initial doses into 20 million people before the end of the year.

Moncef Slaoui, a science adviser for Operation Warp Speed, said last week the federal government can ensure only distribution of the doses to the states and not their administration.

The operation still projects that vaccines will be available to the general public by March or April — after health care personnel, other frontline workers, older adults and people who have chronic health conditions — and to any American who wants one by the end of June or so.

“We’ve come this far, this fast, but we need to get to the finish line,” said National Institutes of Health Director Francis S. Collins. “That will require multiple vaccines using different approaches to ensure everyone is protected safely and effectively from this deadly disease.”

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