COVID-19 Upates (10-22-21)

PHE Extended

On October 18, 2021, the U.S. Department of Health and Human Services announced that the Public Health Emergency (PHE) has been extended for 90 days from October 18, 2021 until January 16, 2022. The CMS 1135 waiver flexibilities will remain in effect as long as a COVID-19 public health emergency is in effect.

Additionally, as a provision of Section 3706 of the CARES Act, hospice physicians and nurse practitioners may continue to conduct recertification face-to-face encounters through telehealth “during the COVID-19 emergency period.”

President Biden Announces COVID-⁠19 Vaccination Plan for Kids Ages 5-11

On October 26th, the FDA’s independent advisory committee will meet to discuss recommendation of the Pfizer COVID-19 vaccinations for children 5-11 years old. The CDC’s independent advisory committee will convene afterwards, on November 2nd and 3rd. 

In anticipation of eventual approval resulting from the recommendations from these meetings, the Biden Administration announced a plan last Wednesday to ensure that the vaccine would be quickly distributed and available to families across the country. Download the Fact Sheet from the White House website.

FDA Advisers Support Johnson & Johnson Vaccine Booster

As reported by Roll Call, “Advisers to the Food and Drug Administration voted, 19-0, to authorize a Johnson & Johnson COVID-19 booster shot at least two months after the first dose, providing some reassurance to the 14 million Americans who received its vaccine and face a higher risk of mild cases than other vaccinated people. FDA and Centers for Disease Control and Prevention officials said at the meeting that real-world evidence suggests the single dose shot is less effective than the Pfizer-BioNTech and Moderna vaccines, including against hospitalization. Johnson & Johnson argued two doses of its vaccine would ramp up efficacy to 94 percent, comparable to those other authorized vaccines.”

As reported by Axios, “The Food and Drug Administration and Centers for Disease Control and Prevention will likely allow recipients of the Johnson & Johnson COVID-19 to mix and match vaccine boosters depending on their individual health. Fauci acknowledged that data suggests that boosting the J&J vaccine with one of the mRNA vaccines produces more antibodies than a second shot of the J&J vaccine.”

Booster dose of Pfizer/BioNTech coronavirus vaccine shows 95.6% efficacy in Phase 3 trial, companies say