- The Food and Drug Administration could authorize two vaccines in the next couple of weeks, and close to 100 million people could be vaccinated as soon as mid-March.
- FDA has authorized multiple treatment options for patients with varying severity of illness due to COVID-19.
- The RADx initiative led by the National Institutes of Health has supported 22 companies to produce more than 1.5 million diagnostic tests per day by the end of the year.
Operation Warp Speed is on target to deliver safe and effective treatments and vaccines for the novel coronavirus. Two drug manufacturers – Pfizer and Moderna – have applied for emergency use authorization from the FDA after clinical trials on their vaccine candidates demonstrated about 95 percent efficacy.
The director of the Centers for Disease Control and Prevention has warned that the winter months could be “the most difficult time in the public health history of this nation” with increased SARS-CoV-2 infections and related hospitalizations. To curb spread of the virus, CDC recommends people avoid holiday travel and continue to use effective tools like staying home when sick, wearing a mask in public, keeping social distance, washing hands, and getting a flu shot.
Effective Vaccines advancing
Operation Warp Speed, with Congress’ support, has successfully expedited the timeline for developing, manufacturing, and allocating effective vaccines. The federal government has provided $18 billion for vaccine and treatment research, with $12.5 billion of this spent on vaccines alone.
On November 20, Pfizer submitted a request to the FDA seeking emergency use authorization for its vaccine after its Phase 3 clinical study showed an efficacy rate of 95%. The federal government already has an agreement with Pfizer to purchase 100 million doses of its vaccine, with the option to purchase an additional 500 million doses. The FDA considered Pfizer’s request at a December 10 meeting of the Vaccines and Related Biological Products Advisory Committee, and recommended its authorization. Moderna filed an emergency use authorization request with the FDA on November 30 for its vaccine candidate, which showed efficacy of more than 94% in its Phase 3 clinical study. Moderna’s request is scheduled to be considered at a December 17 VRBPAC meeting. Vaccine manufacturers will continue to monitor study participants for two years to evaluate long-term protection and safety.
On December 1, the CDC Advisory Committee on Immunization Practices met to consider and vote on recommendations as interim guidance regarding which priority groups should receive the initial doses of COVID-19 vaccines. The advisory committee voted 13 to 1 to recommend states give first priority to health care workers and long-term care facility residents and staff. On December 3, CDC announced that the director had signed and formally endorsed ACIP’s recommendations. The panel will update its recommendations based on emerging evidence and issue additional guidance on who should get the first doses of specific vaccines shortly after the FDA authorizes their use.
Moncef Slaoui, chief scientific advisor to OWS, said on December 6 that the United States may be able to vaccinate most of the 100 million people “highly susceptible” to COVID-19 by mid-March. Army General Gustave Perna, chief operating officer of OWS, has suggested that COVID-19 vaccine doses will be ready for distribution to states within 24 hours of FDA issuing an emergency use authorization. CDC has already worked with 64 jurisdictions to develop specific vaccine and distribution plans so that each state will be ready to utilize vaccine doses once they are available. HHS is also collaborating with CVS and Walgreens to administer vaccines in long-term care facilities.
New Treatments available
The NIH also is leading a partnership – called Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV – to coordinate the efforts of federal agencies, drug manufacturers, universities, private and public organizations, and the European Medicines Agency to develop treatments and vaccines.
On November 9, the FDA issued an emergency use authorization for Eli Lilly and Company’s investigational monoclonal antibody treatment, known as bamlanivimab. The following day, the federal government announced plans to distribute initial doses of the treatment for non-hospitalized patients with moderate COVID-19 who are at high risk of developing a more severe case. The treatment is administered intravenously to patients in outpatient facilities. Bamlanivimab is being evaluated in clinical trials by Lilly and through ACTIV. The federal government plans to allocate doses weekly to states and territories based on their confirmed COVID-19 cases. The government initially purchased 300,000 doses of the treatment and can purchase up to 650,000 additional doses if necessary through June 30, 2021.
On November 21, the FDA authorized Regeneron Pharmaceuticals Inc.’s monoclonal antibodies – casirivimab and imdevimab – to be used together for the treatment of mild to moderate COVID-19 in patients 12 years and older with high risk of hospitalization. These treatments are used in outpatient settings through intravenous infusion.
In October, FDA approved Gilead’s application for remdesivir to treat COVID-19 in hospitalized patients 12 years and older.
|Making testing accessible and affordable is considered an important part of slowing the spread of COVID-19. Under the $2.5 billion Shark Tank-style RADx program, the National Institutes of Health continues to work with the private sector and other federal agencies to produce diagnostic tests that can provide quick, inexpensive results. The RADx initiative has supported 22 companies with manufacturing expansion contracts. NIH projects that this will add the capacity for more than 1.5 million tests per day by the end of the year. This increased capacity is in addition to other efforts at the Department of Health and Human Services to help increase testing capacity.|
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