January 10, 2022, 10:12 a.m. News Staff — During the holiday season and into the first week of 2022, the federal government has taken several actions in response to the spread of the omicron variant of COVID-19, and the Academy is making sure members are up to date on these developments and armed with practical information and tools they can use to deliver optimal patient care.
The following briefly summarizes some of the latest developments in the ongoing battle against COVID-19.
On Jan. 5, CDC Director Rochelle Walensky, M.D., endorsed a recommendation from the Advisory Committee on Immunization Practices issued earlier that day to recommend a single booster dose of the Pfizer-BioNTech mRNA vaccine for individuals 12 to 17 years old at least five months following the primary series. Additionally, the CDC updated recommendations to shorten the timeframe for booster doses from six to five months for individuals who have completed a primary series of the Pfizer-BioNTech or Moderna mRNA vaccines and to allow for an additional dose of the Pfizer-BioNTech vaccine for children 5 to 11 years old who have moderate to severe immunosuppression. These recommendations are consistent with amendments authorized by the FDA.
The AAFP approved the advisory committee’s recommendation after conducting an expedited review of the evidence, and has updated its COVID-19, COVID-19 Vaccine and COVID-19 Vaccine for Children and Adolescents webpages with the latest information.
Walensky’s endorsement allows family physicians and other health care professionals to administer booster doses of the vaccine to eligible adolescents and teenagers.
The ACIP approved a recommendation that children 12 to 15 years old should receive a single booster dose of the Pfizer-BioNTech vaccine at least five months after receiving their primary series of vaccinations by a 13-1 vote following a review of updated safety and effectiveness data. For 16- and 17-year-olds, the CDC recommendations were updated to state that these individuals “should” receive a booster shot; it previously said they “may” receive a booster shot.
On Jan. 4, the CDC updated its isolation and quarantine recommendations for the general population to help “facilitate individual social and well-being needs, return to work and maintenance of critical infrastructure.” Notably, the recommendations say individuals with a presumed or confirmed COVID-19 infection should stay home and isolate from other people for at least five full days, with day 0 being the first day of symptoms or, for those who are asymptomatic, the day of a positive viral test. These individuals should also wear a mask around others at home and in public or an additional five days.
The recommendations also provide guidance on whether individuals should quarantine (and how they should quarantine, if necessary), along with guidance on ending isolation for individuals who had COVID-19 and were symptomatic; those who tested positive for COVID-19 but were asymptomatic; and people who became severely ill from COVID-19 or are immunocompromised.
It should be noted that different recommendations for health care professionals, released in December, outline key points for work restrictions and crisis staffing due to the rapid spread of the omicron variant.
The CDC has also updated quarantine guidance for schools that are consistent with these changes.
The CDC said the best approach for people who have COVID-19 and want to be tested again during isolation is to use an antigen test near the end of the five-day isolation period. Those who test positive should continue to isolate until day 10, while those who test negative can stop being isolated but should continue to wear a well-fitting mask around others at home and in public until day 10.
Additional guidance on who should get tested, when to get tested, and the types of tests available is on the CDC’s COVID-19 Test for Current Infection webpage.
In late December, the FDA granted emergency use authorizations for a pair of antiviral medications for the treatment of mild to moderate COVID-19:
Molnupiravir is authorized for the treatment of mild to moderate COVID-19 in adults who have tested positive for SARS-CoV-2 infection, are at high risk for progression to severe COVID-19, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. It should be taken as soon as possible after diagnosis of COVID-19 and within five days of symptom onset, and is administered via four 200-milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules. It is not recommended for individuals who are pregnant.
Molnupiravir is not authorized for use in patients younger than 18 years, as it may affect bone and cartilage growth. In addition, it is not authorized for the pre-exposure or post-exposure prevention of COVID-19, or for initiation of treatment in patients hospitalized due to COVID-19.
Paxlovid is authorized for the treatment of mild to moderate COVID-19 in adults, as well as in children age 12 years or older who weigh at least 40 kilograms (about 88 pounds), who have tested positive for SARS-CoV-2 and are at high risk for progression to severe COVID-19. Like molnupiravir, it should be taken as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. It is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice a day for five days, for a total of 30 tablets.
Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19, or for initiation of treatment in those who require hospitalization due to severe COVID-19. In addition, Paxlovid is not authorized for use for longer than five consecutive days. There are numerous drug interactions that may alter the dosing or use of this antiviral.
The federal government has purchased about 3 million courses of molnupiravir and 20 million courses of Paxlovid. Production of both medications is expected to increase rapidly in the next few months, with the White House expecting 4 million courses of Paxlovid to be available by the end of January, and up to 10 million courses to be available by June. Both oral antivirals will be distributed by the federal government to individual states and jurisdictions for allocation to health care facilities and pharmacies; availability and access will vary.
Additional information on these and other treatment options is available on the Academy’s COVID-19: Clinical Resources & Patient Education webpage.
Since the start of the COVID-19 pandemic, the Academy has routinely provided information on vaccines for children and adolescents when available, along with resources from the CDC and other agencies to assist AAFP members in preparing to administer the COVID-19 vaccines.
Staff and medical experts at the Academy have also continued to update resources and content on AAFP.org and familydoctor.org to keep members apprised of the latest information. The Academy’s COVID-19 and COVID-19 Vaccine webpages have the latest data on the pandemic and the vaccines used to fight COVID-19, along with information on recent and upcoming FDA and ACIP meetings, educational materials, AAFP advocacy and more.