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CDC Backs FDA's Decision to Reduce Time Between Primary Series and Booster Dose of Pfizer's Covid-19 Vaccine

CNN

The US Food and Drug Administration on Monday expanded the emergency use authorization for Pfizer's Covid-19 vaccine boosters to children ages 12 to 15.

The agency also shortened the time needed before receiving a booster shot from at least six months after completion of the initial series to at least five months, for everyone 12 and older.

"Throughout the pandemic, as the virus that causes Covid-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind," FDA Acting Commissioner Dr. Janet Woodcock said in a statement. "With the current wave of the omicron variant, it's critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight Covid-19."

The US Centers for Disease Control and Prevention on Tuesday backed the FDA's decision to shorten the interval between an initial series of Pfizer's vaccine and a booster shot, but plans to meet with their vaccine advisory board on Wednesday to discuss the issue of expanding booster eligibility to adolescents.

The FDA updated the emergency use authorization after review of real-world data from Israel that showed there were "no new safety concerns" in expanding boosters to adolescents or shortening the timeframe between the initial series and a booster dose.

Specifically, the data showed there were no new cases of myocarditis or pericarditis reported among adolescents who received a booster, according to a statement from the FDA.

The rapid rise in cases across the country made it clear that the benefits of expanding booster eligibility clearly outweighed the risks, FDA leaders said on a call with reporters Monday...

...The FDA on Monday also authorized a third dose as part of the primary series for certain immunocompromised children ages 5 to 11, including those who have received an organ transplant

The CDC agreed with the FDA on this, consistent with their recommendation for adults who are moderately or severely immunocompromised...

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Here's a Guide to CDC’s New Covid-19 Quarantine and Isolation Recommendations

From CNN's Jamie Gumbrecht

The US Centers for Disease Control and Prevention on Monday released new isolation and quarantine guidelines for people infected with or exposed to Covid-19.

Important to note: These are guidelines, not mandates, but many industry groups and organizations use them to set their own policies. While these guidelines offer more detail, the old adage applies: If you feel sick, stay home.

Here is a list of basic things to know:

For people who test positive for Covid-19:

  • Stay home and isolate for five days, regardless of whether you have symptoms. For symptomatic people, Day 1 is the first full day after symptoms developed.
  • If you have no symptoms OR if symptoms are resolving after five days, you can leave isolation but should wear a mask around others — even at home — for five more days.
  • If you have a fever — even a low fever that is going down — you should continue to isolate until your temperature is normal. 
  • There’s no need to test out of isolation after five days; tests can remain positive for months after Covid-19 infection, although you are no longer infectious. 

For people exposed to Covid-19:

These are based on what studies show about how and when people are likely to infect others.

If you are boosted, have received your first two Pfizer or Moderna doses in the last six months or your single J&J dose in the last two months: 

  • No need to quarantine at home after exposure.
  • Always wear a mask around others for 10 days.
  • Test if you develop symptoms, or five days after exposure. People can be infected even without symptoms.
  • If you test positive, you should begin to follow isolation guidelines.

If you are unvaccinated, or are eligible for a booster and haven’t received one: 

  • Quarantine at home for five days, and continue to wear a mask around others for five more days to be sure you don’t infect someone else.
  • Test if you develop symptoms or five days after exposure.
  • If you test positive, you should begin to follow isolation guidelines.
 

CMS Posts Vaccine Order Guidance for Surveyors

On December 28, 2021, CMS posted a memorandum to State Survey Agency Directors, providing guidance and survey procedures for assessing and maintaining compliance with the vaccine mandate regulatory requirements. The memo can be read at:

Guidance for the Interim Final Rule - Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination (QSO-22-07-ALL)

Enforcement remedies for home health and hospice agencies include civil monetary penalties, payment denials and – as a final measure- termination of participation in Medicare and Medicaid programs.

State, Federal, Accreditation, and CMS-contracted surveyors will begin surveying for compliance as part of initial certification, recertification, reaccreditation, and complaint surveys beginning on January 27, 2022 (30 days after issuance of the memo). Facilities failing to maintain compliance with the 100% standard may be subject to enforcement action within 90 days of the memo. 

The memo includes attachments for provider-specific expectations and guidance. Links to those for hospice and home health follow:

 

US Sets Shorter COVID-19 Isolation Rules for Healthcare Workers

Modern Healthcare

Worried that a new COVID-19 wave could overwhelm understaffed U.S. hospitals, federal officials loosened rules that call on healthcare workers to stay out of work for 10 days if they test positive.
 
Those workers now will be allowed to come back to work after seven days if they test negative and don't have symptoms. Isolation time can be cut to five days, or even fewer, if there are severe staffing shortages, according to the new Centers for Disease Control and Prevention guidance.
 
"As the healthcare community prepares for an anticipated surge in patients due to omicron, CDC is updating our recommendations to reflect what we know about infection and exposure in the context of vaccination and booster doses," CDC Director Rochelle Walensky said in a statement.
 
"Our goal is to keep healthcare personnel and patients safe, and to address and prevent undue burden on our healthcare facilities," she added.
 
Isolation is designed to keep infected people away from uninfected people, to prevent further spread of the virus.
 
CDC officials have advised that in calculating the 10-day isolation period, the first day should be the first full day after symptoms first developed or after a positive test. If a person develops symptoms sometime after a positive COVID-19 test, the quarantine period must restart, beginning one day after the symptoms develop.

 

OSHA Withdraws Most Provisions of the Healthcare ETS

From the National Association for Home Care and Hospice

On June 21, 2021, OSHA adopted a Healthcare Emergency Temporary Standard (Healthcare ETS) protecting workers from COVID-19 in settings where they provide healthcare or healthcare support services. 86 FR 32376. Under the OSH Act, an ETS is effective until superseded by a permanent standard – a process contemplated by the OSH Act to occur within 6 months of the ETS’s promulgation. 29 U.S.C. 655(c).

OSHA announces today that it intends to continue to work expeditiously to issue a final standard that will protect healthcare workers from COVID-19 hazards, and will do so as it also considers its broader infectious disease rule making. However, given that OSHA anticipates a final rule cannot be completed in a timeframe approaching the one contemplated by the OSH Act, OSHA also announces today that it is withdrawing the non-record keeping portions of the healthcare ETS. The COVID-19 log and reporting provisions, 29 CFR 1910.502(q)(2)(ii), (q)(3)(ii)-(iv), and (r), remain in effect. These provisions were adopted under a separate provision of the OSH Act, section 8, and OSHA found good cause to forgo notice and comment in light of the grave danger presented by the pandemic. See 86 FR 32559.

With the rise of the Delta variant this fall, and now the spread of the Omicron variant this winter, OSHA believes the danger faced by healthcare workers continues to be of the highest concern and measures to prevent the spread of COVID-19 are still needed to protect them. Given these facts, and given OSHA’s anticipated finalization of this rule, OSHA strongly encourages all healthcare employers to continue to implement the ETS’s requirements in order to protect employees from a hazard that too often causes death or serious physical harm to employees.

As OSHA works towards a permanent regulatory solution, OSHA will vigorously enforce the general duty clause and its general standards, including the Personal Protective Equipment (PPE) and Respiratory Protection Standards, to help protect healthcare employees from the hazard of COVID-19. The Respiratory Protection Standard applies to personnel providing care to persons who are suspected or confirmed to have COVID-19. OSHA will accept compliance with the terms of the Healthcare ETS as satisfying employers’ related obligations under the general duty clause, respiratory protection, and PPE standards. Continued adherence to the terms of the healthcare ETS is the simplest way for employers in healthcare settings to protect their employees’ health and ensure compliance with their OSH Act obligations.

OSHA believes the terms of the Healthcare ETS remain relevant in general duty cases in that they show that COVID-19 poses a hazard in the healthcare industry and that there are feasible means of abating the hazard. OSHA plans to publish a notice in the Federal Register to implement this announcement.

It is unclear what OSHA’s expectations are for providers in relation to its Vaccination and Testing ETS if healthcare providers continue to follow the provisions of the OSHA Healthcare ETS. The National Association for Home Care & Hospice will continue to follow the developments closely and provide updates as we learn more.    

 
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