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Operation Warp Speed is looking to start distributing COVID-19 vaccine by mid-month

There should be enough of the vaccine for every American who wants it, by spring, HHS Secretary Alex Azar says.

Susan Morse, Managing Editor

The federal government is looking to have a COVID-19 vaccine ready for distribution to states and federal agencies by mid-December, according to Operation Warp Speed officials speaking during a briefing on Wednesday.

If all goes well, the Department of Health and Human Services could make its first shipments of the vaccine this month and is on track to be able to ship enough vaccines for 20 million Americans before the end of the year, HHS Secretary Alex Azar said. There should be enough of the vaccine for every American who wants it by spring, he said.

Dr. Moncef Slaoui, chief advisor to Operation Warp Speed, said he feels confident that they will be able to distribute enough vaccine to immunize 20 million people in the United States in December; 30 million people in January; and 50 million people in February. 

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"And, end of February, we will have potentially immunized a 100 million people, which is really more or less the size of the significant at risk population, the elderly, the healthcare workers, the first line workers, people with comorbidity," Slaoui said.

Priority will be given to frontline healthcare workers, those at greatest health risk and the elderly. 

Moderna has 94.1% efficacy against moderate and severe disease and Pfizer has shown similar data on efficacy, Slaoui said. There are 6.4 million doses of the Pfizer vaccine available and 12.5 million doses of the Moderna vaccine. Both vaccines need booster shots within three or four weeks of the first dose.

Another being developed by Johnson & Johnson, is hoped to be a one-shot vaccine, officials said. More candidates, such as one from AstraZeneca, are in the final stages of clinical trials.

Moderna and Pfizer are ready to go, both having filed for emergency use authorization with the Food and Drug Administration. The FDA has scheduled a meeting of its vaccine advisory committee to review the Pfizer vaccine on December 10 and the Moderna vaccine on December 17.

HHS learned on Wednesday that the United Kingdom has granted authorization to the Pfizer vaccine, Azar said.

Also, Pfizer and Moderna have both applied for their coronavirus vaccines to be approved in the European Union, according to The Wall Street Journal.

DISTRIBUTION

On Tuesday, the Centers for Disease Control and Prevention held a meeting of its advisory committee on immunization practices, which issued recommendations on vaccine distribution, which will now be used by states.

There are allocations scheduled for 64 jurisdictions for a fair and equitable allocation based on population, according to General Gustave F. Perna, chief operations officer for Operation Warp Speed. The 64 jurisdictions include the 50 states, eight territories and six mega cities, as well as five federal agencies.

Half of the doses will be sent initially, with the second half going out 21 days later for the Pfizer vaccine and 28 days later for the Moderna vaccine, so as to not overwhelm capacity and to make sure the second dose is on hand, Perna said.

Operation Warp Speed has collaborated with CVS, Walgreens and other private pharmacies to enable the states' plans in distributing the vaccine.

COVID-19 THERAPIES

COVID-19 antibody treatments are available and are recommended to Americans over the age of 65 who have the coronavirus in order to prevent hospitalization.

CVS Health said it has been selected by HHS, as part of Operation Warp Speed, to pilot the administration of a limited supply of bamlanivimab, a monoclonal antibody therapy, for eligible COVID-19 patients at risk of severe infection or complications resulting from the virus. 

Under this pilot, Coram, the specialty pharmacy and infusion care business of CVS Health, will administer the intravenous therapy in patients' homes or long-term care facilities. The pilot will be available in seven cities and their surrounding communities starting Thursday, December 3. Following the pilot, Coram will scale this solution to additional markets in areas of greatest need.

To be eligible, and in accordance with the therapy's Emergency Use Authorization, patients must not be hospitalized, be within 10 days of symptom onset, be least 12 years of age or older, weigh at least 88.2 pounds, and be at high risk for progressing to severe disease and/or hospitalization.

There is no out-of-pocket cost to the patient.

HHS is also looking for those who have recovered from COVID-19 within the last three months for plasma donations.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com