The CDC, HHS, and NIH along with other top health leaders announced on Wednesday, August 18, their recommendation and plans to offer COVID-19 booster shots to many Americans [i] . This guidance, for people who have already received the full course of the Pfizer or Moderna vaccine, would amount to a third dose. Why was this recommendation made now?
Why is a booster dose needed?
According to the CDC, COVID-19 vaccines are working as expected [ii] . Even with variants like Delta, they are preventing severe illness, hospitalization, and death. Citing studies that suggest the vaccines lose efficacy over time especially against variants, CDC director Dr. Rochelle Walensky explained, “our plan is to protect the American people, to stay ahead of this virus.” [iii] This echoed what Dr. Anthony Fauci said referring to one of the key lessons learned so far, that it is best to “stay ahead of it than chase after it.” So, the third dose is needed to boost the effectiveness of the vaccines mainly due to highly contagious variants, and preliminary evidence showing protection from the vaccines has lowered in those first vaccinated in January 2021. [iv]
How is this different from the previous direction for certain immunocompromised individuals?
This is different from the direction given earlier on August 12 [v], in which the FDA recommended certain immunocompromised individuals to receive a third dose of Pfizer or Moderna twenty-eight days after their second dose. The third dose for the immunocompromised is part of their initial vaccination protocol to be considered fully vaccinated. Whereas the third dose to be received by the general public is a booster shot to be given to those already considered fully vaccinated. This booster shot would come eight months after receiving the second dose of Pfizer or Moderna COVID-19 vaccines.
What is the third dose?
Whether it’s a booster or an additional dose due to being immunocompromised, the third dose of mRNA vaccine (Pfizer and Moderna) will be identical to the first and second doses already received. This third dose would also be dispensed in the same way as the first two.
Who will receive an additional dose?
There are two groups of people who are currently targeted for an additional shot of mRNA (Pfizer and Moderna) vaccine: (1) certain immunocompromised people twenty-eight days after their second dose and (2) fully vaccinated people eight months after their second dose of mRNA vaccine. At this time, people who received the single dose of Johnson & Johnson’s Janssen vaccine are not included as there is not enough data yet to make that decision. [vi]
Which people qualify for the third dose?Studies [vii] have indicated that fully vaccinated, moderately to severely immunocompromised people, account for a large portion of hospitalized breakthrough cases, and are more likely to transmit the virus [viii] . Who does the CDC include in that group? Download the most current list for an easy reference:
When can those eligible get the additional dose?
For the immunocompromised, they can receive their third dose of mRNA vaccine now, provided it has been twenty-eight days since their second dose. Fourteen days after the third dose, they will then be considered fully vaccinated.
For everyone else who has received their second dose of mRNA vaccine, the goal is for the roll-out to begin in early fall, which would be right at eight months after those first vaccinated received their second doses. From that point, people would become eligible in the eighth month following their second dose. Before this can start, the boosters need to be approved by the FDA and recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP). The FDA is currently conducting its independent evaluation of the booster dose to confirm effectiveness and safety. The expectation is the FDA and the ACIP will announce their approval and recommendation very soon.
Will additional boosters be needed in the future?
At this time, there is no further guidance provided after the first booster shot. The expectation is that the effectiveness of the boosters will be closely monitored, and further direction based on the current COVID-19 environment would be forthcoming.
Will people vaccinated with Johnson & Johnson Janssen COVID-19 vaccine also need a booster?
At this time, there is not enough data to confirm it, however, the CDC believes it’s likely that those vaccinated with the Johnson & Johnson Janssen Covid vaccine will need a booster dose. The first doses of the Johnson & Johnson Janssen Covid vaccine came seventy days after the mRNA doses, so they expect to be able to make a recommendation on this soon. [ix]
How can we protect our communities?
As more studies and data become available, we can expect to receive updated guidance about boosters from the CDC, NIH, and HHS. Without a doubt, COVID-19 will continue to evolve with new and existing variants testing our mitigation and control measures. Our response must also continue to be flexible, determined, and resilient. Awareness and education about distancing, masks, and vaccination are the best ways we can prepare our communities. We have been on the COVID-19 frontlines since the very beginning, and we are ready to help you as a trusted partner in your ongoing effort to protect your community. Let’s talk.
REFERENCES & RESOURCES
- NBC Boston. (n.d.). Feds Call for Booster Shots for All Americans, Vaccination of Nursing Home Staff. [online] Available at: https://www.nbcboston.com/news/coronavirus/us-announces-plan-to-offer-covid-booster-shots-for-all-americans/2469790/ [Accessed 27 Aug. 2021].
- CDC and CDC (2021). COVID-19 Booster Vaccine. [online] Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html.
- NBC Boston. (n.d.). Feds Call for Booster Shots for All Americans, Vaccination of Nursing Home Staff. [online] Available at: https://www.nbcboston.com/news/coronavirus/us-announces-plan-to-offer-covid-booster-shots-for-all-americans/2469790/.
- NBC Boston. (n.d.). 3rd Dose of COVID Vaccine? What We Know About Booster Shots So Far. [online] Available at: https://www.nbcboston.com/news/local/3rd-dose-of-covid-vaccine-what-we-know-about-booster-shots-so-far/2469819/ [Accessed 27 Aug. 2021].
- NBC Chicago. (n.d.). FDA Approves 3rd Vaccine Dose for Immune-Compromised Ahead of CDC Meeting. [online] Available at: https://www.nbcchicago.com/news/coronavirus/extra-covid-vaccine-okd-those-with-weak-immune-systems/2589549/ [Accessed 27 Aug. 2021].
- CDC and CDC (2021). COVID-19 Booster Vaccine. [online] Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html.
- Oliver, S. and Meeting, A. (2021). cdc.gov/coronavirus Data and clinical considerations for additional doses in immunocompromised people. [online] . Available at: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-07/07-COVID-Oliver-508.pdf [Accessed 27 Aug. 2021].
- CDC and CDC (2021). COVID-19 Vaccination. [online] Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html.
- CDC and CDC (2021). COVID-19 Booster Vaccine. [online] Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html.
- outbreak.info. (n.d.).outbreak.info. [online] Available at: https://outbreak.info/situation-reports?pango=C.1.2&loc=ZAF&selected=ZAF [Accessed 16 Sep. 2021].
- The continuous evolution of SARS-CoV-2 in South Africa: a new lineage with rapid accumulation of mutations of concern and global detection – 24 August 2021. Available at: https://www.medrxiv.org/ .
By: Erik McLaughlin MD, MPH and Aikaterini Papadopoulou, B.Arch
