Pandemic Puts Scientists, Medical Groups, Federal Agencies at Odds

Misinformation has been the enemy of truth during a pandemic that now has exceeded two years and taken a million lives, but there also has been genuine scientific disagreement that would seem inevitable given the many variables of the response.

For example, the rollout of the newly minted bivalent vaccines containing an Omicron component is going concerningly slow. It was recently estimated that only 4% of the targeted population has received the shots, although half of the shots were given to those older than 65 years of age — a known risk group.¹

The new bivalent booster by Pfizer-BioNTech is recommended for people 12 years of age and older. A similar bivalent booster by Moderna is recommended for those 18 years of age and older. There appears to be some level of “booster fatigue,” since only about half of the people who originally received the two-shot series by these same companies received a third dose booster recommended last year. While the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) approved and strongly recommended the new bivalent boosters — citing an anticipated winter surge of COVID-19 — there has been scientific pushback as well as public apathy.

Only two members the FDA’s vaccine advisory panel advisory committee voted against recommending the new bivalent vaccine boosters at a meeting in late June of this year. Unfortunately, one of them was Paul Offit, MD, one of the foremost vaccine experts in the country and director of the Vaccine Education Center at Children’s Hospital of Philadelphia (CHOP). Saying the primary goal of a vaccine is to prevent serious illness, hospitalization, and death, Offit said at the FDA meeting that there were insufficient data that the bivalent booster will aid in that cause. Offit, who declined to be interviewed by this publication, posted a Sept. 2, 2022, video statement clarifying his view as director of the CHOP vaccine center position on the bivalent vaccines and booster doses in general.

Before development of the bivalent boosters, when the original messenger ribonucleic acid (mRNA) two-dose vaccines were the initial regimen, “the CDC found that if you gave three doses you were less likely to become hospitalized as compared to people who received two doses,” Offit said in the video.² “Later they did studies showing that if you received four doses you were less likely to be hospitalized than those who received three doses. But the critical question is who was getting hospitalized if they only received two doses and not three? Who was getting hospitalized if they only received three doses instead of four? The answer is not everybody. It really came down to three groups. One were the elderly, people over 65 [years of age]. [Secondly], were people who had serious medical conditions, such as longstanding lung disease. Even a mild infection could land those people in the hospital. And the third group were people who were immune compromised. So I think, moving forward, the best way to make sense of these bivalent booster doses … is for people in those three groups to get them. Otherwise, I think a healthy young person doesn’t necessarily need this vaccine.”

Public enemy No. 1 to the anti-vaccine movement — during the false claims that autism was linked to measles shots — Offit is known as a voice of credibility and to speak with the courage of his convictions. But if the bivalent booster has poor public uptake, possibly even in the at-risk groups he cited, there could, by some estimates, be disastrous results.

If the relatively modest immunization levels of the 2020-2021 flu season (50% in adults, 59% in children³) are achieved with the new bivalent boosters by Dec. 31, 2022, 75,000 lives could be saved, according to a modeling analysis by the Commonwealth Fund.⁴

In general, those gains were realized by comparing the old flu vaccination rates against continuation of the current low baseline of bivalent vaccination. A healthcare quality advocacy group, the Commonwealth Fund evaluated the effect of “accelerated delivery of booster doses” on reducing hospitalizations, deaths, and direct medical costs. The latter was aimed directly at Congressional funding for vaccine programs, since the analysis showed $44 million in costs averted in saving those lives and preventing about 745,000 hospitalizations.

Thus, the pandemic has pushed us to the limits of science, trying to take the best approach to risks and benefits in the absence of compelling data and an unknown future.

APIC Urges IPs to Keep Masking

In another example of this quandary, the CDC faces unusual pushback from the Association for Professionals in Infection Control and Epidemiology (APIC), which strongly disagrees with the CDC’s revised guidelines that would relax some masking recommendations in healthcare.⁵

“Despite CDC’s recent guidance shift that relaxes recommendations for universal healthcare personnel masking, APIC strongly urges its 15,000 infection preventionist members to maintain mandatory mask requirement policies for healthcare employees in all patient care areas,” the association said in a statement.⁶ “While APIC understands that many healthcare employees have grown weary of masking, we do not believe it is wise to discontinue this evidence-based, COVID-19 mitigation strategy — especially as we enter what is predicted to be a severe flu season, with COVID-19 surges looming on the horizon.”

There are some language differences that muddy the waters on this issue, as the CDC guidelines use the term “source control” and APIC refers to “masking.” The CDC states that source control options of healthcare workers include N95 respirators and a “well-fitting facemask.” In most cases, source control protects the patient, thus the use of masks in surgery. However, the CDC calls for wearing an N95 if caring for a patient with confirmed or suspected COVID-19.

“The Sept. 23, 2022, [revised guidelines] lift universal masking recommendations for healthcare personnel,” APIC charges. “Instead, CDC suggests that healthcare facilities use its Community Transmission levels as a guide for when source control is necessary for healthcare personnel. Based on these updates, healthcare facilities in geographic areas with low levels of community spread may relax their employee masking requirements.”

The CDC states that, “when SARS-CoV-2 Community Transmission levels are high, source control is recommended for everyone in a healthcare setting when they are in areas of the healthcare facility where they could encounter patients.” As of Oct. 8, 2022, 51% of U.S. counties had high transmission rates, with the remaining categories broken down as “substantial” (26%), moderate (18%), and low (5%).⁷ The CDC recommends this same level of source control when the “Community Level” — a different metric based in part on hospitalizations — is designated as high. By this measure in the same time period, only 3% of communities were at a high level and 77% were listed as low.⁸

This reflects, in part, continuing transmission but milder infections. “Updates were made to reflect the high levels of vaccine- and infection-induced immunity and the availability of effective treatments and prevention tools,” the CDC explains in the guidelines.

At any rate, CDC guidelines are voluntary, and healthcare facilities can continue to base masking policies on their own judgment of their situation and the risk to their patients and healthcare workers.

In an additional caution, APIC points out that there is a seven-day lag in CDC COVID-19 testing data, which may limit the ability to detect surges in real time.

“Requiring masks of anyone who enters a healthcare setting, including employees, helps to ensure the safest environment for our patients,” APIC emphasizes. “Our members clearly understand that the pandemic is not over. Numerous indicators, including wastewater surveillance and rising case counts overseas, point to a potential wave of new COVID-19 cases in the coming months. When that happens, we will have to shift back to universal masking. Having a policy that changes back and forth is confusing to healthcare personnel and erodes trust.”

REFERENCES

1. Diamond D, Gahan MB, Johnson M. Few Americans get new covid booster shot ahead of projected winter surge. The Washington Post. Updated Oct. 7, 2022. https://www.washingtonpost.com/health/2022/10/07/covid-booster-winter-surge/
2. Offit P. COVID-19: What is the bivalent vaccine & who should get it as a booster dose? Children’s Hospital of Philadelphia Vaccine Education Center. Last reviewed Sept. 12, 2022. https://www.chop.edu/centers-programs/vaccine-education-center/video/covid-19-what-bivalent-vaccine-who-should-get-it-booster-dose
3. Centers for Disease Control and Prevention. Flu vaccination coverage, United States, 2020-21 influenza season. Published Oct. 7, 2021. https://www.cdc.gov/flu/fluvaxview/coverage-2021estimates.htm
4. Fitzpatrick MC, Shah A, Moghadas SM, et al. A fall COVID-19 booster campaign could save thousands of lives, billions of dollars. The Commonwealth Fund. Published Oct. 5, 2022. https://www.commonwealthfund.org/blog/2022/fall-covid-19-booster-campaign-could-save-thousands-lives-billions-dollars
5. Centers for Disease Control and Prevention. Interim infection prevention and control recommendations for healthcare personnel during the coronavirus disease 2019 (COVID-19) pandemic. Updated Sept. 23, 2021. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html?utm_source=newsletter&utm_medium=email&utm_content=Infection%20Control%3A%20Severe%20acute%20respiratory%20syndrome%20coronavirus%202%20%28SARS-CoV-2%29%20%7C%20CDC&utm_campaign=COMMS%20%7C%20CDC%20Update%209/23
6. Association for Professionals in Infection Control and Epidemiology. APIC urges IPs to continue universal masking in patient care areas. Published Oct. 3, 2022. https://apic.org/news/apic-urges-ips-to-continue-universal-masking-in-patient-care-areas/#:~:text=Arlington%2C%20Va.%2C%20October%203,in%20all%20patient%20care%20areas
7. Centers for Disease Control and Prevention. COVID-19 integrated county view. Community transmission. Oct. 8, 2022. https://covid.cdc.gov/covid-data-tracker/#county-view?list_select_state=all_states&list_select_county=all_counties&data-type=Risk&null=Risk
8. Centers for Disease Control and Prevention. COVID-19-integrated county view. Community levels. Oct. 6, 2022. https://covid.cdc.gov/covid-data-tracker/#county-view?list_select_state=all_states&list_select_county=all_counties&data-type=CommunityLevels&null=CommunityLevels