Laura is the editorial director of The American Journal of Managed Care® (AJMC®) and all its brands, including The American Journal of Accountable Care®, Evidence-Based Oncology™, and The Center for Biosimilars®. She has been working on AJMC® since 2014 and has been with AJMC®'s parent company, MJH Life Sciences, since 2011. She has an MA in business and economic reporting from New York University.
In a briefing, the White House COVID-19 Team discussed the first guidance from the CDC on activities that individuals fully vaccinated against COVID-19 can safely resume, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, gave an update on antiretroviral drug development.
Individuals who are fully vaccinated against COVID-19 will be able to meet in small, private gatherings with other vaccinated individuals or low-risk individuals who are unvaccinated without masking or social distancing, according to the CDC.
The agency released long-awaited guidelines for fully vaccinated people with the caveat that the guidance is not final and will be updated based on the level of community spread and the proportion of the population that is fully vaccinated. In addition, the CDC is still recommending that fully vaccinated individuals continue to wear masks in public, maintain distance, and follow other public health measures.
The CDC considers an individual fully vaccinated after they have received the second dose of the 2-dose vaccines from Pfizer/BioNTech or Moderna or at least 2 weeks after receiving Johnson & Johnson’s single-dose vaccine.
The guidance comes shortly after some states have announced they are lifting mask mandates and ready to fully reopen. On March 2, Governor Greg Abbott announced that he was lifting Texas’ mask mandate and opening businesses and facilities to 100% capacity. The New York Times reported that Massachusetts is allowing restaurants to operate without limits, Mississippi ended its mask mandate, and South Carolina removed limits on large gatherings.
In a news conference with the White House COVID-19 Team, CDC Director Rochelle P. Walensky, MD, MPH, noted that 59 million individuals in the United States have received at least 1 dose of a vaccine and 31 million individuals are fully vaccinated.
“We’ve been through a lot this past year, and with more and more people getting vaccinated each day, we are starting to turn a corner,” she said. “And as more Americans are vaccinated, a growing body of evidence now tells us that there are some activities that fully vaccinated people can resume at low risk to themselves.”
Clinical trial data has shown that COVID-19 vaccines are highly effective at protecting vaccinated individuals against severe illness, hospitalization, and death, but there remains a small risk that they can become infected with a mild disease or be asymptomatic and potentially transmit the disease to unvaccinated individuals, Walensky said. As the science of COVID-19 evolves, the recommendations will be updated.
“Importantly, our guidance must balance the risk to people who have been fully vaccinated, the risk to those who have not yet received a vaccine, and the impact on the larger community transmission of COVID-19,” she said.
The guidance focuses on activities that fully vaccinated individuals can resume in a private setting. Fully vaccinated individuals can visit in small gatherings indoors, in a private setting without masks or distancing. The scenario becomes a little more complicated if vaccinated people are meeting with unvaccinated people.
In a scenario where fully vaccinated people are visiting one household of unvaccinated people, people do not need to wear masks or distance as long as they, and members of their household, are not considered high risk for COVID-19. If the fully vaccinated people are visiting a household with anyone who is considered high risk, everyone, “regardless of vaccination status,” should wear a mask and distance, as well as meet either outdoors or in a well-ventilated place. Walensky reminded that anyone over the age of 65 and people with underlying conditions such as cancer, heart disease, or diabetes are at higher risk of severe disease.
In situations where fully vaccinated people are meeting with unvaccinated people from multiple households, everyone should wear a mask, distance, and meet outdoors.
The CDC also provided guidance on quarantining. People who are fully vaccinated will no longer need to quarantine or get tested if they are asymptomatic after they are exposed to someone with COVID-19.
In addition, the CDC is continuing to recommend that everyone, whether or not they are vaccinated, avoid medium and large gatherings and wear a mask, distance, and follow other public health measures when in public spaces.
Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, also spoke and provided an update on the future of investigational direct-acting antivirals against SARS-CoV-2, highlighting how the process is akin to the successful development of antiviral drugs for HIV.
The replication cycles of SARS-CoV-2 and HIV are similar, he said. As with the HIV replication cycle, creating targeting therapeutics to fight the virus that causes COVID-19 will involve identifying vulnerable targets in the SARS-CoV-2 replication cycle and then designing the drugs to block those targets and prevent the individual virions from releasing.
In HIV, he noted, this research, targeting fusion and entry inhibitors, reverse transcriptase inhibitors, integrase inhibitors, and protease inhibitors, paved the way for drug classes that led to “an extraordinary number of drugs which when used in combinations has transformed the life of HIV-infected individuals giving them an almost normal lifespan, although the drug needs to be given, essentially, for the rest of their lives.”
The replication cycle of SARS-CoV-2 is similar, with viral entry and viral release; Fauci said that areas of current development in investigational direct-acting antivirals include entry inhibitors, polymerase inhibitors, and protease inhibitors, ranging from the preclinical stage to phase 2a.
There is 1 polymerase inhibitor approved, remdesivir from Gilead Sciences. Another candidate, molnupiravir from Ridgeback Biotherapeutics and Merck, showed a faster decrease in time to negativity of infectious virus in symptomatic patients, according to early trial results released this weekend.
Despite the positive news, officials continued to urge caution, given that there are still about 60,000 new cases a day in the United States and most of the country remains unvaccinated. The CDC did not update its travel guidance and continues to recommend that everyone avoid nonessential travel.
This is “a first step, not our final destination,” Walensky noted, adding that CDC will update these guidelines as more people are vaccinated and as understanding of vaccination immunity evolves.
“COVID-19 continues to exact a tremendous toll on our nation,” she said. “Like you, I want to be able to return to everyday activities and engage with our friends, families, and communities.”