The COVID-19 pandemic is forcing a lot of rule changes by many different agencies. There are relaxed rules on providing telehealth services, for example. We discussed telehealth rule changes previously.
So far, there are no rule changes from FDA regarding the authorized dosages for the two mRNA vaccines.
FDA has approved some food labeling changes primarily because it’s more difficult, during the health crisis, to obtain some ingredients.
The Department of Health and Human Services has created a list of frequently asked questions and answers about using telehealth during the COVID-19 emergency
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
The good news is that several COVID-19 vaccines have already received Emergency Use Authorization from the Food and Drug Administration (FDA). These vaccines include products from Pfizer and Moderna. Other vaccines may be approved shortly. There are many issues involving the efficacy of the vaccines. Some of these issues include:
- Determining how well the vaccines work against new strains of the virus.
- How many vaccines can be manufactured and what is the timeline for their manufacture?
- What are the logistics for moving the vaccines from the manufacturing sites to the states and into the arms of the people who need them?
- Which people should receive the vaccines first?
One question that was recently addressed by FDA, on January 4, 2021, is the dosing schedule for the vaccines. The FDA Center for Biologics Evaluation and Research issued a press release from the FDA Commissioner from the Director of the Center.
According to the release, the two approved vaccines have shown 95% effectiveness in preventing COVID-19 disease in adults. Nearly 20 million people have received at least one vaccination, as of January 27, 2021. FDA issued the press release because many of the people who have been vaccinated are now eligible for a second dose. The press release also emphasizes that the public should understand the importance of “receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.”
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The question of the timing of the second dose
The FDA press release observed that there has been much discussion about:
- Reducing the number of doses
- Extending the length of time between doses
- Changing the dose (half-dose)
- Mixing and matching vaccines
The discussion is all in an effort to help immunize more people against COVID-19 – especially because the number of people who have died due to COVID-19 has reached 400,000. Some hospitals are now being forced to prioritize which patients can be admitted or treated.
The press release states that these changes/questions are all reasonable issues to review and evaluate in clinical trials. However, the press release states that:
“Suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.”
As of the date of the press release, FDA states that the current data support giving people two doses of the vaccine according to the following schedules.
- For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second doses.
- For the Moderna COVID-19 vaccine, the interval is 28 days between the first and second doses.
Part of the reason FDA suggests continuing with the above schedules is that the clinical data for those people who did not receive a second dose is insufficient. The people who received just the first dose were only followed, in the clinical studies, for a short while. FDA states it “cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies. “
The press release added that in the phase 3 trials, “98% of participants in the Pfizer-BioNTech trial and 92% of participants in the Moderna trial received two doses of the vaccine at either a three- or four-week interval, respectively.”
FDA emphasizes that the single dose option and the administration of less than the full dose option are concerning – because there isn’t a proper understanding as to the duration and depth of the protection of these options. There is thus a potential for harm because the people who receive the vaccines won’t be able to know how much protection the vaccine provides. These people may improperly assume they are being fully protected when they are not. People who falsely think they are protected may be in danger of contracting COVID-19 and in danger of transmitting COVID-19 to others.
FDA recognizes why the discussion is taking place – the belief that a change in the doses of the two vaccines or a change in the schedule may help vaccinate more people. While understandable, FDA believes that dosing changes which aren’t adequately supported by scientific evidence may ultimately do more harm than good to the public’s health.
The press release emphasizes that the agency is committed to making health decisions based on the available data and science. FDA continues to recommend that vaccinations be given according to the FDA-authorized dosing schedules for the corresponding COVID-19 vaccine – until the manufacturers of the vaccine have updated data and science which justifies a change in the dosing schedules.
FDA is a US Department of Health and Human Services agency that:
“Protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
Dr. Anthony Fauci, the nation’s leading infectious disease expert, in a recent interview with CNN and a recent appearance on NBC supports FDA’s position. He stated, “The issue of giving it to people and not having a guarantee you’re going to get a second shot goes against the science.” “We want to do it according to the science. You give a first dose. If you have a Pfizer, 21 days later, you get a boost. If you have the Moderna, 28 days later, you get the boost.”
The Current CDC vaccination schedule recommendations
As of January 8, 2021, the US Centers for Disease Control and Prevention (CDC) recommends that the available COVID-19 vaccines be given to people in a specific priority order. The CDC emphasizes that the available supply is currently limited – which is why priorities need to be set. These guidelines may change as the available supply increases. The CDC recommendations are for the federal, state, and local government. The recommendations are based on guidelines from the Advisory Committee on Immunization Practices (ACIP), an independent panel of medical and public health experts.
The aims of the recommendations are to:
- Reduce the deaths and serious disease effects as much as possible
- “Preserve functioning of society.”
- “Reduce the extra burden COVID-19 is having on people already facing disparities.”
Ultimately, each state determines who receives the vaccinations first and how and where the people in those states are vaccinated. Residents of each state should contact their local health department for more information about when and where the residents can receive an approved COVID-19 vaccine.
The CDC priority list is as follows:
Phase 1a. Healthcare personnel and residents of long-term care facilities should be offered the first doses of COVID-19 vaccines.
- Healthcare Personnel
- Long-term Care Facility Residents
- Frontline essential workers. These people include: “firefighters, police officers, corrections officers, food and agricultural workers, United States Postal Service workers, manufacturing workers, grocery store workers, public transit workers, and those who work in the educational sector (teachers, support staff, and daycare workers.”
- People aged 75 years and older. These people have priority “because older people are at high risk of hospitalization, illness, and death from COVID-19. People aged 75 years and older who are also residents of long-term care facilities should be offered vaccination in Phase 1a.”
- People aged 65—74 years. People in this age bracket have priority because seniors are at high risk of hospitalization, illness, and death from COVID-19. If the people in this age bracket are also long-term care facility residents, these people should be offered vaccination in Phase 1a.
- People aged 16—64 years with “underlying medical conditions which increase the risk of serious, life-threatening complications from COVID-19.”
- Other essential workers. These people provide essential services to the public and the community. This category includes “people who work in transportation and logistics, food service, housing construction and finance, information technology, communications, energy, law, media, public safety, and public health.”
It’s expected that:
- Phase 1a will cover about 24 million people
- Phase 1b will cover about 49 million people
- Phase 1c will cover about 140 million people
Relaxed Food Labeling Requirements
According to Food and Wine, FDA has loosened some of its food labeling requirements for ingredient substitutions during the COVID-19 pandemic. The changes are meant to provide more flexibility due to disruptions in the food chain. The changes can be found on the FDA website – Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines (fda.gov)
The aim of the relaxed guidelines, according to the agency is “To provide regulatory flexibility, where appropriate, to help minimize the impact of supply chain disruptions on product availability associated with the current COVID-19 pandemic.”
FDA states that there are still specific criteria that must be met.
Of primary importance is safety. Any substituted ingredient must “not cause any adverse health effect (including food allergens, gluten, sulfites, or other foods known to cause sensitivities in some people).”
The relaxed labeling requirements also address other concerns such as health claims, nutrition, functionality, quantity, and prominence. The changes don’t authorize the removal of a “characterizing ingredient.” For example, the manufacturers can’t omit raisins in a raisin bread food product.
FDA does recognize, for example, that there isn’t enough bleaching agent to bleach flour. The new labeling rules allow for “temporary flexibility for the substitution of unbleached flour for bleached flour without a corresponding label change while there continue to be bleached flour shortages.”
There is some concern that these de-regulations may extend beyond the pandemic emergency, according to The Washington Post. “FDA says the agency will take comments and consider an extension beyond the public health emergency.”
FDA is concerned about getting the approved FDA EUA vaccines into the arms of as many people as possible. Still, FDA places a priority on the scientific data presented by Pfizer and Moderna, the makers of mRNA vaccines that require two full doses. FDA will relax rules when necessary to help people survive the pandemic, such as some food labeling laws, but only if it’s clear that the risk factor of loosening the rules isn’t too great.
Physicians and healthcare providers should contact Cohen Healthcare Law Group, PC for legal advice about FDA vaccine and COVID-19 requirements. Our experienced healthcare attorneys will review the current compliance demands.