Credit ACIP/CDC
#16,131
It has become increasingly apparent over the past couple of months that the Delta variant represents an enhanced pandemic threat over the Alpha variant and the 2020 `wild type' virus (see The CDC `The War Has Changed' Internal Document On Delta Variant), and that our current vaccines - while still very protective against severe illness - are vulnerable to breakthrough infections from Delta.
In recent weeks, we've also seen evidence that the protection from the mRNA vaccines begins to wane after a few months (see UK REACT-1 Study (Round 13) Finds Fully Vaccinated Have 50% to 60% Reduced Risk of Infection With COVID), raising concerns over the need for a 3rd booster shot, particularly for the immunocompromised.
Increasingly, however, it's become apparent that eventually everyone would need a booster shot. In July Pfizer openly discussed the possibility, and two weeks ago, in Moderna To Investors: 3rd COVID Booster Shot Will Be Needed by Winter, we saw additional evidence presented supporting the need for a 3rd shot.
This is obviously not the messaging that public health would like to deliver right now - with so many people still hesitant to receive their first vaccine - and with many parts of the world unable to offer a vaccine at all.
But the writing is on the wall, and today the directors and leading researchers from the HHS, CDC, FDA, and other public health agencies signed onto the following joint release, which outlines the need for a 3rd booster for mRNA vaccine recipients (and likely for J&J vaccine recipients) in the coming months.
The bottom line: Assuming both the FDA and ACIP sign off on it, the U.S. government is , . . . prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose.
The full announcement follows:
FOR IMMEDIATE RELEASE
August 18, 2021
Contact: HHS Press Office
202-690-6343
media@hhs.gov
Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots
Today, public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan for COVID-19 booster shots for the American people.
The statement is attributable to Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC); Dr. Janet Woodcock, Acting Commissioner, Food and Drug Administration (FDA); Dr. Vivek Murthy, U.S. Surgeon General; Dr. Francis Collins, Director of the National Institutes of Health (NIH); Dr. Anthony Fauci, Chief Medical Advisor to President Joe Biden and Director of the National Institute of Allergy and Infectious Diseases (NIAID); Dr. Rachel Levine, Assistant Secretary for Health; Dr. David Kessler, Chief Science Officer for the COVID-19 Response; and Dr. Marcella Nunez-Smith, Chair of the COVID-19 Health Equity Task Force:
“The COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant. Recognizing that many vaccines are associated with a reduction in protection over time, and acknowledging that additional vaccine doses could be needed to provide long lasting protection, we have been analyzing the scientific data closely from the United States and around the world to understand how long this protection will last and how we might maximize this protection.The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease.Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.
“We have developed a plan to begin offering these booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence. We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster. We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them.
“We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine. Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.
“Our top priority remains staying ahead of the virus and protecting the American people from COVID-19 with safe, effective, and long-lasting vaccines especially in the context of a constantly changing virus and epidemiologic landscape. We will continue to follow the science on a daily basis, and we are prepared to modify this plan should new data emerge that requires it.
“We also want to emphasize the ongoing urgency of vaccinating the unvaccinated in the U.S. and around the world. Nearly all the cases of severe disease, hospitalization, and death continue to occur among those not yet vaccinated at all. We will continue to ramp up efforts to increase vaccinations here at home and to ensure people have accurate information about vaccines from trusted sources. We will also continue to expand our efforts to increase the supply of vaccines for other countries, building further on the more than 600 million doses we have already committed to donate globally.”
While vaccinated are currently pretty well protected against serious illness and death from COVID, this announcement warns `. . . the current protection against severe disease, hospitalization, and death could diminish in the months ahead . . ', which - if it happens - could prove a major setback against the COVID pandemic.
While I'm quite grateful to be vaccinated, I rolled up my sleeve fully knowing that its protection would probably be limited, both in effectiveness and duration. As we discussed in October of last year (see A COVID Vaccine Reality Check) - while badly needed to save lives - a vaccine was unlikely to be a panacea for this pandemic.
Although the Delta variant currently has the United States, Europe, and much of the world fully in its grip, there are other variants (like Epsilon, Lambda, and Beta) that have have even greater vaccine evasion abilities in the wings.
Meaning that we may find ourselves needing either a new vaccine, or another booster, in the fall of 2022 as well.
