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March 10, 2021

CDC Interim Recommendations for Fully Vaccinated People: An Important First Step

Author Affiliations
  • 1Centers for Disease Control and Prevention, Atlanta, Georgia
JAMA. 2021;325(15):1501-1502. doi:10.1001/jama.2021.4367

On December 11, 2020, the US reached an extraordinary milestone in the efforts to end the COVID-19 pandemic: the Food and Drug Administration authorized emergency use of the first COVID-19 vaccine, manufactured by Pfizer-BioNTech. Since then, 2 additional COVID-19 vaccines, Moderna and Janssen (Johnson & Johnson), have received Emergency Use Authorization in the US and, as of March 8, 2021, more than 31 million people, or 9.4% of the total population, have completed a vaccination series.1

With the number of people vaccinated each week continuing to increase, the Centers for Disease Control and Prevention (CDC) has released its initial public health recommendations for fully vaccinated people (individuals who are at least 2 weeks out from having received their second Pfizer-BioNTech or Moderna vaccine dose, or from their Janssen single-dose vaccine).2 These recommendations represent the first step for individuals in resuming their prepandemic lives.

When creating this guidance, the risks to both vaccinated and unvaccinated people were considered. Current data demonstrate that the authorized COVID-19 vaccines are efficacious among adults of different ages, races, and ethnicities, and among those with underlying medical conditions.3 Even if fully vaccinated people do become infected, they are much less likely to develop severe disease, be hospitalized, or die.3

In addition, preliminary but rapidly increasing evidence suggests that fully vaccinated people likely pose little risk of transmission to unvaccinated people. Studies from the US, UK, and Israel found that 2 doses of Pfizer-BioNTech or Moderna vaccines were 86% to 92% effective against asymptomatic and symptomatic SARS-CoV-2 infection.3 More specifically, studies from Israel demonstrated that the Pfizer-BioNTech COVID-19 vaccine was 90% effective against asymptomatic infection, and vaccinated people who developed COVID-19 had a substantially lower viral load than unvaccinated people.3 Viral load has been identified as a key driver of transmission and this observation may indicate reduced transmissibility. Collectively, these findings demonstrate that vaccination has the potential to substantially reduce the COVID-19 disease burden in the US.

Although scientists have already learned a great deal about SARS-CoV-2 and how well the authorized COVID-19 vaccines perform, some questions remain. Researchers are still investigating how long protection from natural infection or vaccination lasts and how well the vaccines protect against emerging SARS-CoV-2 variants. A recent analysis that assessed the 4 major types of immune memory found substantial durability 6 months after natural infection.4 Although they remain rare, cases of reinfection have been reported.5 Because of these data, vaccination is recommended for individuals who have recovered from COVID-19.6 Data from the phase 3 vaccine trials and vaccine effectiveness studies will help to understand how well COVID-19 vaccines provide long-term protection. If and when the level of neutralizing antibody that correlates with protection against SARS-CoV-2 is identified, more will be learned about how natural and vaccine-derived immunity may compare.

Additionally, the authorized COVID-19 vaccines may provide protection against many well-described SARS-CoV-2 variants.3 However, reduced vaccine efficacy and antibody neutralization have been observed for the B.1.351 variant,3 originally identified in South Africa, and currently reported from 20 US jurisdictions.7 CDC and state, local, and academic partners are rapidly scaling up genomic surveillance to understand how widely these variants have dispersed across the US and to identify new variants as they emerge. The CDC and others are also monitoring the effects of specific mutations on the authorized COVID-19 vaccines, therapeutics, and diagnostic tests.

Despite these unknowns, fully vaccinated people can resume several activities now, at low risk to themselves, while being mindful of the potential risk of becoming infected and transmitting the virus to other people. With the new CDC recommendations (Box), fully vaccinated people can share a meal or movie night in their private residence, without masks or physical distancing. Fully vaccinated people can also do these things with unvaccinated family and friends; however, prevention measures (such as wearing masks and physical distancing) should be maintained if any unvaccinated people are at risk of severe COVID-19 or if multiple households of unvaccinated people are mixing together.

Box Section Ref ID
Box.

Background Rationale and Data for Public Health Recommendations for Fully Vaccinated People

  • COVID-19 vaccines currently authorized in the US are effective against COVID-19, including severe disease.

  • Preliminary evidence suggests that the currently authorized COVID-19 vaccines may provide some protection against a variety of strains, including B.1.1.7 (originally identified in the UK). However, reduced antibody neutralization and efficacy have been observed for the B.1.351 strain (originally identified in South Africa).

  • A growing body of evidence suggests that fully vaccinated people are less likely to have asymptomatic infection and potentially less likely to transmit SARS-CoV-2 to others. However, further investigation is ongoing.

  • Modeling studies suggest that preventive measures such as mask use and social distancing will continue to be important during vaccine implementation. However, there are ways to take a balanced approached by allowing vaccinated people to resume some lower-risk activities.

  • Taking steps toward relaxing certain measures for vaccinated persons may help improve COVID-19 vaccine acceptance and uptake.

  • The risks of SARS-CoV-2 infection in fully vaccinated people cannot be completely eliminated as long as there is continued community transmission of the virus. Vaccinated people could potentially still get COVID-19 and spread it to others. However, the benefits of relaxing some measures, such as quarantine requirements, and reducing social isolation may outweigh the residual risk of fully vaccinated people becoming ill with COVID-19 or transmitting the virus to others.

  • Guidance for fully vaccinated people is available and will continue to be updated as more information becomes available.

From the CDC recommendations.3

In addition, most fully vaccinated people will no longer have to be tested for SARS-CoV-2 infection or quarantine if they are exposed to someone with COVID-19, allowing them to go to work, take care of their families, and continue their daily lives (exceptions to this recommendation include patients and residents of congregate settings).

CDC guidance will evolve as vaccination coverage increases, disease dynamics in the country change, and new data emerge. Until then, the CDC will rely on other proven prevention strategies during this critical juncture. With high levels of community transmission and the threat of SARS-CoV-2 variants of concern, CDC still recommends a number of prevention measures for all people, regardless of vaccination status. These include continuing to wear a well-fitted mask when in public or with people at risk of severe COVID-19, avoiding large gatherings, and postponing travel. In addition, community-level prevention strategies must be maintained. To reduce transmission, layered prevention strategies such as universal face mask mandates, and restrictions on occupancy of indoor spaces and the size of social gatherings, are essential. Once vaccinated people make up a greater proportion of the general US population, these community-level restrictions will be readdressed, but not yet.

The promising early data of the COVID-19 vaccines offer a path toward ending this pandemic that has affected everyone’s daily lives in so many ways. Yet some reports suggest that approximately a third of US adults still do not want to get vaccinated.3 As highlighted at the recent National Forum on COVID-19 Vaccine, barriers to vaccine access must be removed and evidence-based approaches to improving vaccine confidence and acceptance are essential.

Day by day, arm by arm, millions of vaccines are being administered across the US in the largest vaccination effort in this country’s history. As vaccine supply increases, and distribution and administration systems expand and improve, more and more people will become fully vaccinated and eager to resume their prepandemic lives. Giving vaccinated people the ability to safely visit their family and friends is an important step toward improved well-being and a significant benefit of vaccination.

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Article Information

Corresponding Author: Athalia Christie, MIA, Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333 (akc9@cdc.gov).

Published Online: March 10, 2021. doi:10.1001/jama.2021.4367

Conflict of Interest Disclosures: None reported.

Additional Contributions: We wish to acknowledge Heidi M. Soeters, PhD (CDC).

References
1.
Centers for Disease Control and Prevention. CDC COVID data tracker: COVID-19 vaccinations in the United States. Accessed March 7, 2021. https://covid.cdc.gov/covid-data-tracker/#vaccinations
2.
Centers for Disease Control and Prevention. Public health recommendations for fully vaccinated people. March 8, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html
3.
Centers for Disease Control and Prevention. Science Brief: background rationale and data for public health recommendations for fully vaccinated people. March 8, 2021. https://www.cdc.gov/coronavirus/2019-ncov/more/fully-vaccinated-people.html
4.
Dan  JM, Mateus  J, Kato  Y,  et al.  Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection.   Science. 2021;371(6529):eabf4063. doi:10.1126/science.abf4063Google Scholar
5.
Centers for Disease Control and Prevention. Interim guidance on retesting and quarantine of adults recovered from laboratory-diagnosed SARS-CoV-2 infection with subsequent re-exposure. Accessed March 7, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html#anchor_1613167560916
6.
Centers for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines currently authorized in the United States. Accessed March 7, 2021. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
7.
Centers for Disease Control and Prevention. US COVID-19 cases caused by variants. Accessed March 7, 2021. https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html
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    5 Comments for this article
    EXPAND ALL
    Some Guidance is Better Than No Guidance But a Long Road Ahead!
    Manish Joshi, MD | CAVHS
    As we mark the first anniversary of the declaration COVID-19 pandemic by WHO, the CDC’s interim COVID-19 guidelines are welcomed which will now allow the vaccinated people to resume the simple activities such as meeting with close family members -the one which we have taken granted until a year ago. But we would like to suggest that people who have recovered from COVID-19 with natural-infection-immunity should also be allowed to resume the same activities. After all, the theoretical concept of herd-immunity includes immunity both due to the natural infection and due to vaccination. Natural infection-induced immunity is currently playing a major role to fight this pandemic in resource limited countries with very limited supply of vaccines (1).

    It is interesting that in this viewpoint, the rationale for immunization of people who have recovered from COVID-19 is reports of rare re-infections; one could argue that there is no perfection with either immunity from natural infection or vaccines (with efficacy 86% to 92% mentioned in this viewpoint). More so, the data in the vaccine trials (both Pfizer and Moderna) do not suggest efficacy among participants with evidence of previous SARS-CoV-2 infection (2). One could also argue that the duration of immunity due to natural infection is unknown (3), but so is the duration of immunity due to available vaccines. In our opinion, the wisest application of current knowledge and reason would be to not overlook the commonsense approach when there are global vaccine shortages. Swift and appropriate deployment of this valuable resource- the vaccine- can make a real difference globally to fight against this pandemic.

    Reference

    1. Kuehn BM. High-Income Countries Have Secured the Bulk of COVID-19 Vaccines. JAMA. 2021;325(7):612. doi:10.1001/jama.2021.0189
    2. https://wwmt.com/news/nation-world/questions-arise-over-cdc-guidance-on-covid-19-vaccines
    3. Harvey RA, Rassen JA, Kabelac CA, et al. Association of SARS-CoV-2 Seropositive Antibody Test With Risk of Future Infection. JAMA Intern Med. Published online February 24, 2021. doi:10.1001/jamainternmed.2021.0366
    CONFLICT OF INTEREST: None Reported
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    The CDD Guidance is Functionally Incomplete.
    Robert Blasdell, Ph.D. | (A rural volunteer fire deparment)
    The new CDC guidance removing the necessity of wearing masks in certain gatherings consisting entirely of fully vaccinated individuals is of obvious practical interest and importance to rural fire departments and EMS agencies which have historically held a variety of types of joint Fire - EMS - Law Enforcement trainings and would like to do so again. It is quite likely that other types of fully vaccinated workers and/or non-profit volunteer groups have similar functional (rather than political or academic) interest in the functional specifics of this new guidance. Such organizations have a very high level of contact with the public, and so whatever actual actions they take will have wide ranging consequences. It would be good if those consquences were not bad. CDC guidance needs to be clear, numerically specific, and algorithmically complete in order facilitate this.

    The new CDC guidance would have been quite useful to such groups if it had been functionally complete. As provided, it is not. Among other issues (that others are better equipped to debate), the guidance -- as stated -- is rather obviously provided only for Small Gathering (or Group) size and the upper and lower size boundaries for such Gathering Size is nowhere defined on the CDC site despite the fact that Gathering Size Categories are used in a functionally critical manner in various other CDC COVID-19 public safety guidance. This is an absolutely critical point, and it is not unique to this particular guidance or just to guidance from the CDC.

    Worse, the algorithmic logic of this CDC guidance is both unnecessarily vague and "dis-associated" with regards to Gathering Size. The reader has to do a bit of backtracking and corrective editing of the guidance to deduce that it only applies to Small Gatherings. (The guidance states, again less clearly than it should, that it does not apply to gatherings of Medium or Large Gatherings of fully vaccinated individuals. From this, one logically deduces that it only applies to Small Gatherings. As various news media have subtly pointed out in articles covering this new guidance, none of the Gathering Sizes: Small, Medium, Large or Mass seem to be defined anywhere in the CDC website or public releases.)

    This situation is a bit worse than well-educated academics might tend to assume because very few of the above noted interested parties are apt to have the prior applied technical mathematical experience (from an empirical "hard" science and/or engineering background) to immediately notice the above noted omissions as part of any cursory reading of the guidance (which is all most are likely to do). Also, they are similarly unlikely to make one subtle but obvious observation. The relevant group (or gathering size) boundaries for uniform increases in expected risk are simplistically expected to scale as the square root of the risk increment. Or said the other way round, the risk is (simplistically) expected to be proportional to the square of the group size. Because of this, the Medium and Large group sizes are going to occur a bit "sooner" (at lower group numbers) than the average non-academic reader of the guidance might think -- and because that limit is not actually specified, even if people guess at it, they are likely to guess a bit low. (The April 2, 2020 Science News article by Dana Mackenzie: "How large a gathering is too large during the coronavirus pandemic? The math of social networks can create a roadmap to a group size that still curbs spread" gives approachable references to the math.)
    CONFLICT OF INTEREST: None Reported
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    Pfizer-BioNTech Vaccine Effectiveness Against Asymptomatic Infection
    KS Lam |
    At least 50% of new coronavirus cases stem from asymptomatic people based on study findings by researchers with the Centers for Disease Control and Prevention [1]. Based on the EUA briefing documents submitted by Pfizer, Moderna and Janssen, FDA stated that "Data are limited to assess the effect of the vaccine against transmission of SARS-CoV-2 from individuals who are infected despite vaccination".

    The CDC authors of this article mentioned that "studies from Israel demonstrated that the Pfizer-BioNTech COVID-19 vaccine was 90% effective against asymptomatic infection". However, the Appendix to the NEJM paper [2] includes a footnote which shows that "In
    the absence of systematic periodic testing for SARS-CoV-2 among asymptomatic people in Israel, documented asymptomatic infections do not account for all asymptomatic infections, and likely cannot accurately capture vaccine effectiveness for this outcome". In this light, the observational matched cohort study shows that the 90% vaccine effectiveness against asymptomatic infection is overestimated.

    I am cautiously optimistic about seeing the risk of transmission being reduced moderately in the near future, but the tasks of achieving herd immunity threshold remains challenging.

    References:

    1. SARS-CoV-2 Transmission From People Without COVID-19 Symptoms
    https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2774707

    2. BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting
    https://www.nejm.org/doi/full/10.1056/NEJMoa2101765
    CONFLICT OF INTEREST: None Reported
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    Guidance Based on Immunity Status
    David Bell, MBBS, PhD. | Independent consultant
    It's good to see an important step from CDC in recommending easing of restrictions based on vaccination status. As Christie et al. note, the evidence for maintained functional immunity over 6 months after natural infection is strong and cited as one of the bases of evidence for the post-vaccination recommendations.

    Naturally-acquired immunity may reasonably be expected to be less prone to failure on exposure to genetic variants of SARS-CoV-2, as it may also recognize non-spike protein antigens.

    Therefore anyone post-COVID-19 (or post SARS-CoV-2 asymptomatic infection) might be similarly or better protected and refractory to transmitting to others. />
    It is hoped therefore that CDC will base recommendations on immune status rather than vaccine status, and recognize the protective impact of both vaccination and naturally-acquired infection in their guidance. This would appear to have a sound biological basis, and accelerate the return to a more inclusive economy and society.
    CONFLICT OF INTEREST: None Reported
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    Fully Vaccinated Does Not Imply Surely Protected - Stay Cautious
    Sandro Tsang, PhD | People's Open Access Education Initiative
    This paper presents evidence to imply that the COVID-19 vaccines will get us back to 'normal' lives soon. We cannot derive policies based on optimism. Lessening the restrictions for the fully vaccinated may be a particularly risky recommendation. Supposing that the vaccines are 100% effective and all individuals are fully vaccinated, our lives will never be the same as if we were in the pre-COVID-19 era. We still cannot precisely predict when microbes will further evolve, and the behaviours of the new strains. If we did, the outbreak would not evolve into a pandemic of this scale that lasts so long. No one can guarantee that the SARS-COV-2 variants will not further evolve into other more lethal strains. We can only prepare for living in 'new normal' lives. I also suspect that a substantial proportion of the fully vaccinated individuals are individuals given priorities to receive the vaccines; i.e., vulnerable individuals, including immunocompromised patients. I commented earlier that “[w]e really do not know how safe [and effective] the vaccines are to [them]” (1, 2), and that “[they] are a growing subpopulation worldwide” (2). They need to be more cautious than the rest of the population even if they are fully vaccinated. The pandemic has evolved at this scale partially due to the slow responses to the outbreak. We should adapt from this lesson of over-optimism for future health policy-making. The public should be educated to stay cautious at all times regardless the vaccination phrase.

    References

    1. Blumenthal, K. G., Robinson, L. B., Camargo, C. A., Shenoy, E. S., Banerji, A., Landman, A. B., & Wickner, P. (2021). Acute Allergic Reactions to mRNA COVID-19 Vaccines. JAMA. doi:10.1001/jama.2021.3976.1. Blumenthal, K. G., Robinson, L. B., Camargo, C. A., Shenoy, E. S., Banerji, A., Landman, A. B., & Wickner, P. (2021). Acute Allergic Reactions to mRNA COVID-19 Vaccines. JAMA. doi:10.1001/jama.2021.3976.

    2. Moore, J. (2021). Experts Discuss COVID-19 - Variants and Vaccine Efficacy, Immunosuppressed Patients, and More. JAMA. doi:10.1001/jama.2021.5938.
    CONFLICT OF INTEREST: None Reported
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