- Important vaccine news; data on hospital capacity; more payment info from CMS.
IMPORTANT VACCINE NEWS
As noted below, today the FDA’s Vaccines and Related Biological Products Advisory Committee recommended that the FDA issue an emergency use authorization (EUA) for Pfizer’s vaccine. This is among the final steps before the FDA issues an EUA. The FDA could issue an EUA for Pfizer’s vaccine as early as Friday. Vaccines will be distributed within 24 hours of FDA authorization. The same Advisory Committee will convene to review Moderna’s vaccine candidate on December 17.
White House and Federal Agencies
- The Department of Health and Human Services (HHS) released new hospital COVID-19 capacity data at the facility level. Previously released data about hospital capacity was aggregated at the state level. This new, more granular, data release aggregates daily hospital reports into a “week at a time” picture.
- The Centers for Medicare and Medicaid Services (CMS) sent a letter to all Governors on strategies for updating hospital capacity in light of increasing hospitalizations due to COVID-19.
- CMS published new information about how it covers and reimburses monoclonal antibody treatments for COVID-19.
- The Department of Health and Human Services (HHS) will distribute $523 million in second round performance payments to over 9,000 nursing homes. These nursing homes are being rewarded for successfully reducing COVID-19 related infections and deaths between September and October.
Centers for Disease Control and Prevention (CDC) Updates
- CDC updated its resource page on vaccinations. The webpage provides information for healthcare professionals on preparing for vaccinations, preparing patients, and the process for vaccine approval.
- CDC updated:
- its webpage with FAQs on Clinical Questions about COVID-19.
- Information for Clinicians on Investigational Therapeutics for Patients with COVID-19. CDC strongly encourages clinicians, patients and their advocates, and health system administrators to regularly consult the COVID-19 Treatment Guidelines published by the National Institutes of Health (NIH). The treatment and management recommendations in these guidelines are based on scientific evidence and expert opinion and are frequently updated.
- information on When to Quarantine – Stay at Home When Exposed.
- its information on Treatments that your Healthcare Provider Might Recommend if you are Sick. Treatments used for COVID-19 should be prescribed by your healthcare provider. People have been seriously harmed and even died after taking products not approved for COVID-19, even products approved or prescribed for other uses.
- its information on protecting yourself during the holiday season.
- its FAQs related to Travel and COVID-19.
- testing information on who should get tested, how to get tested and how to understand testing results.
- its information for Workplaces and Businesses.
- its webpage on Things to Know about the COVID-19 Pandemic.
- its information on Ventilation. Protective ventilation practices and interventions can reduce the airborne concentration, which reduces the overall viral dose to occupants.
- its information on COVID-19 and Animals. Based on the limited information available to date, the risk of animals spreading COVID-19 to people is considered to be low.
- CDC Director Dr. Robert Redfield is expecting high levels of COVID-19 deaths for the next 60 days.
Economy, Vaccine, Testing and Treatment
- A Federal Drug Administration (FDA) staff review of Pfizer’s COVID-19 vaccine confirms the vaccine is successful at preventing COVID-19 symptoms.
- The FDA’s Vaccines and Related Biological Products Advisory Committee met today to review Pfizer’s vaccine candidate. This is among the final steps before FDA emergency approval.
- The Advisory Committee recommended that the FDA issues an emergency use authorization (EUA) for Pfizer’s vaccine.
- The federal government will immediately distribute 2.9 million doses of Pfizer’s COVID-19 vaccine upon FDA approval.
- The Department of Defense will immediately distribute 44,000 doses.
- Moderna expects to produce 500 million doses of its COVID-19 vaccine in 2021.
- New data released by AstraZeneca and Oxford University about their COVID-19 vaccine candidate suggests it will not be as effective as the candidates from Pfizer and Moderna.
- The United Kingdom (U.K.), which recently began vaccinating people against COVID-19, reported some allergic reactions to the vaccine. It is important to note that such reactions are not unexpected with vaccines and in the case of this vaccine they are rare.
- The National Institutes of Health (NIH) no longer recommends remdesivir for patients on mechanical ventilators.
- The coronavirus that causes COVID-19 has mutated into seven strains.
- NIH released information about a NIH-funded tool that helps organizations plan COVID-19 testing. An innovative online tool funded by the NIH helps organizations choose a COVID-19 testing strategy that will work best for their specific needs. The COVID-19 Testing Impact Calculator is a free resource that shows how different approaches to testing and other mitigation measures, such as mask use, can curb the spread of the virus in any organization.
- NIH Director Dr. Francis Collins released a blog post about a study among healthcare workers that shows COVID-19 immunity lasts many months. New findings from a study of thousands of healthcare workers in England show that those who got COVID-19 and produced antibodies against the virus are highly unlikely to become infected again, at least over the several months that the study was conducted.