Update February 5th - February 17th
Welcome to the McGraw-Hill COVID-19 channel. This week we have information on the “best practices” for reopening schools, the tightening of criteria for the use of convalescent serum, a “best practices” note from the FDA on using a single ventilator for two patients, and new recommendations on quarantine after exposure to SARS-CoV-2 in those already vaccinated.
On February 10th, 2021, the CDC changed guidelines regarding quarantine rules in those who have been fully immunized. Allergic contraindications for vaccination have also been updated.
“Vaccinated persons with an exposure to someone with suspected or confirmed COVID-19 are not required to quarantine if they meet all of the following criteria (verbatim):
- Are fully vaccinated (i.e., ≥2 weeks following receipt of the second dose in a 2-dose series, or ≥2 weeks following receipt of one dose of a single-dose vaccine)
- Are within 3 months following receipt of the last dose in the series
- Have remained asymptomatic since the current COVID-19 exposure”
Vaccinated individuals still need to watch for symptoms and signs for 14 days after exposure and, if symptoms develop, continue to follow isolation procedures.
Hopefully this reduces the burden of quarantine in those vaccinated. Note that the period of modified quarantine only lasts for three months after the completed vaccine series. Also note that following patient symptoms is still crucial.
Regarding allergy and contraindications to mRNA vaccines, the current guideline reads:
“Persons with a known (diagnosed) allergy to polyethylene glycol (PEG), another mRNA vaccine component, or polysorbate, have a contraindication to vaccination. There is a precaution to vaccinate persons with a reaction to a vaccine or injectable therapy that contains multiple components, one of which is PEG, another mRNA vaccine component or polysorbate, but in whom it is unknown which component elicited the immediate allergic reaction. The full vaccination update can be found here.
It is still important to be prepared to treat anaphylaxis after COVID-19 immunization, although it remains a rare occurrence.
- CDC Vaccines & Immunizations, mRNA COVID-19 Vaccines. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
The FDA emergency use authorization (EAU) for convalescent serum has been tightened. The new requirements include (verbatim):
- The use of low titer anti-SARS-CoV-2 convalescent plasma is no longer authorized. The new EUA points out that high titer plasma is the only preparation that has been shown effective.
- The use of convalescent plasma is restricted to inpatients and to those outpatients who have impaired humoral immunity (e.g. bone marrow transplant, some chemotherapy, on chronic steroids, etc.).
- The use of convalescent plasma in those with respiratory failure requiring intubation has not been shown to be of benefit.
- FDA In Brief: FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data https://www.fda.gov/news-events/fda-brief/fda-brief-fda-updates-emergency-use-authorization-covid-19-convalescent-plasma-reflect-new-data
The CDC has released new guidelines for reopening schools. These are detailed guides for school reopening including details on mask wearing, physical distancing, handwashing, maintaining and cleaning facilities and contact tracing. They do not mandate vaccines for teachers but rather suggest that they should be prioritized for vaccination along with other frontline workers. Importantly, they are not mandating a return to in-person learning; this is still up to state and local governments. But these guidelines show how to do it safely. These guidelines are detailed and can be found here
- DC COVID-19 Schools & Child Care https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/index.html
Lastly, the FDA has released a best practices recommendation for using ventilator splitters. The current recommendations include (verbatim):
“Health care providers and facilities should review the considerations listed below:
- Consider non-invasive ventilation such as high flow nasal oxygen or non-invasive positive pressure ventilation as a first option prior to using an authorized ventilator splitter.
- If invasive ventilation using an authorized ventilator splitter is the only option:
- Limit sharing of ventilation to two patients,
- Try to match patients based on similar ventilatory requirements,
- Limit duration of sharing ventilation to 48 hours,
- If possible, reserve at least one single patient ventilator for emergencies or to wean a patient off ventilation support
- Consider updated ventilator sharing protocols, such as the New York Presbyterian Ventilator Sharing Protocol: Dual-Patient Ventilation with a Single Mechanical Ventilator for Use during Critical Ventilator Shortages to minimize risk.
- The recent literature indicates that ventilator splitters that incorporate these features may reduce certain risks:
- One-way valves in the breathing circuit,
- Flow restrictors or pressure regulators at each inspiratory limb of the circuit,
- Individual positive end-expiratory pressure (PEEP) valves,
- Inspiratory and expiratory tidal volume sensors, and
- Pressure sensors.”
Hopefully we are beyond the peak that led to ventilator shortages. None-the-less this is important information for those working on inpatient units in case the situation arises again. The full document can be found here.
- FDA: Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers https://www.fda.gov/medical-devices/letters-health-care-providers/using-ventilator-splitters-during-covid-19-pandemic-letter-health-care-providers