As the delivery of COVID-19 vaccines ramps up, it’s important to understand the compliance regulations that affect healthcare practices. The Centers for Disease Control and Prevention lists many of the state and federal laws and rules that apply. These requirements apply to a variety of vaccines, not just COVID-19.
State laws cover a variety of issues including the requirement that healthcare workers get vaccines, and patients in healthcare facilities get vaccines. There are also laws setting the vaccination requirements for children. Some of these requirements include the following:
At the federal level, the Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191), commonly called HIPAA, was enacted to help protect the privacy of healthcare information including vaccination records. Vaccine information must still comply with HIPAA.
HIPAA and Access. Legal Summary and Recent Investigations
The HHS Office of Civil Rights has guidance on how and when covered entities should respond to a right of access request for the personal health information of a patient.
Guidelines for COVID-19 vaccines
The CDC also has Clinical Care Considerations for COVID-19 Vaccination including considerations for each type of emergency use authorization:
“The Advisory Committee on Immunization Practices (ACIP) has issued interim recommendations for the use of Pfizer-BioNTech, Moderna, and Janssen/Johnson & Johnson COVID-19 vaccines for the prevention of coronavirus disease 2019 (COVID-19) in the United States.”
According to the CDC, two of the vaccines (Pfizer-BioNTech and Moderna) are mRNA vaccines. These two vaccines are “lipid nanoparticle-formulated nucleoside-modified” vaccines which encode the “prefusion spike glycoprotein of SARS-CoV-2.” SARS-COV-2 is the virus that causes COVID-19. The Jansen vaccine (manufactured by Johnson and Johnson) is a “recombinant replication-incompetent adenovirus type 26 (Ad26) vector encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2.” None of the three vaccines for COVID-19 are live virus vaccines.
The clinical considerations for the three COVID-19 vaccines are based on data supplied to FDA for emergency use authorization, additional sources of data, general best practice guidelines for immunization, and expert opinion. The clinical considerations provided by the CDC only apply to the two mRNA vaccines and the Jansen vaccine. No other vaccines have been approved yet in the United States. The guideline considerations should be supplemented by examining the information provided by each manufacturer.
Which age groups can use the approved COVID-19 vaccines?
The EUAs authorize vaccine use by age group as follows:
- Pfizer-BioNTech: ages ≥16 years
- Moderna: ages ≥18 years
- Janssen: ages ≥18 years
Children outside these age groups are not authorized to receive the vaccines. Pfizer-BioNTech (and possibly the others) are currently conducting clinical trials on the use of the vaccine by younger people.
People who are receiving either of the two-dose mRNA COVID-19 vaccines or the single-dose of the Janssen COVID-19 vaccine should only receive one “complete COVID-19 vaccination series.”
The time between mRNA doses
The CDC recommends that the second doses of the two mRNA vaccines be administered as close as possible to the recommended time intervals:
- Three weeks for the Pfizer-BioNTech vaccine
- One month for the Moderna vaccine.
Second doses which are “administered within a grace period of 4 days earlier than the recommended date for the second dose are still considered valid.” If the delay is not avoidable, the second doses of the two mRNA vaccines can be administered “up to 6 weeks (42 days) after the first dose. Currently, only limited data are available on the efficacy of mRNA COVID-19 vaccines administered beyond this window.”
Errors in vaccine administration should be reported to the Vaccine Adverse Event Reporting System (VAERS)external icon.
Interchangeability of COVID-19 vaccine products
The Advisory Committee on Immunization Practices (ACIP) doesn’t state a preference among the three approved COVID-19 vaccines. The ACIP does state that the three vaccines are NOT interchangeable.
mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna)
The CDC recommends that both doses of the mRNA vaccine should use the same product. Some of the strategies for helping to ensure that patients get the second dose within a timely manner include:
- Using COVID-19 vaccination cards. These cards record when each dose was given. Recipients will be given a card after the first vaccine – and asked to bring the card to the second vaccine. Recipients will be encouraged to make backups of the card – such as by taking a picture of the vaccination card with a smartphone.
- Vaccine recipients will be encouraged to “enroll in v-safe, a free smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins as well as second-dose reminders.” Another enrollment platform is VaxTextSM.
- Everyone who receives a dose should have a record of the reception recorded in an immunization information system (IIS).
- The receipt of a vaccine (single or double-dose) should also be recorded in each person’s medical record.
- Recipients of a first dose should make an appointment for a second dose before they leave the facility – after the first dose – to help ensure patients receive the second dose at the same location.
“In exceptional situations in which the vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series.”
“The safety and efficacy of Janssen COVID-19 vaccine administered after an mRNA COVID-19 vaccine has not been established. However, in limited, exceptional situations where a patient received the first dose of an mRNA COVID-19 vaccine but is unable to complete the series with either the same or different mRNA COVID-19 vaccine (e.g., due to contraindication), a single dose of Janssen COVID-19 vaccine may be considered at a minimum interval of 28 days from the mRNA COVID-19 vaccine dose.”
FDA Issues Emergency Use Authorization for Pfizer COVID-19 Vaccine
FDA granted an Emergency Use Authorization to a COVID-19 vaccine developed by Pfizer, Inc. Doses of the vaccine have already been administered to health workers
FDA Reviewing Moderna’s COVID-19 Vaccine
An Advisory Panel for the Food and Drug Administration is reviewing a request by Moderna for its COVID-19 vaccine. Moderna’s vaccine is expected to be distributed in the coming months.
Booster doses
To date, no determination has been made that COVID-19 booster shots are necessary. Boosters shots are not recommended at the present time. Booster shots may be considered and/or recommended in time – due to concerns about mutations of the current form of the COVID-19 vaccines.
COVID-19 vaccination and SARS-CoV-2 infection
The CDC also has guidelines for obtaining the vaccine for anyone with a current or prior SARS-CoV-2 infection.
The CDC states that data from clinical trials support the conclusion that the vaccines for COVID-19 that have been approved can “be given safely to people with evidence of a prior SARS-CoV-2 infection.” People should be given the opportunity to take a COVID-10 vaccine – whether or not their SARS-CoV-2 infection was symptomatic or asymptomatic.
The CDC does not recommend viral tests “to assess for acute SARS-CoV-2 infection or serologic testing to assess for prior infection.” However, if a person has a current SARS-CoV-2 infection, the vaccination should be delayed until the person has recovered “from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation.” This CDC guideline applies to someone who experiences a SARS-CoV-2 infection:
- Before receiving the first dose
- After the first dose of an mRNA dose but before they receive the second dose
“Current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. “
Vaccinations for people who previously received passive antibody therapy
There isn’t any current data on how well the three current COVID-19 vaccines might work on people whose COVID-19 treatment included monoclonal antibodies or convalescent plasma as part of COVID-19 treatment. The CDC states that “based on the estimated half-life of such therapies and evidence suggesting that reinfection is uncommon in the 90 days after initial infection, vaccination should be deferred for at least 90 days.” This precautionary step is based on the concern that the antibody therapy might interfere with the vaccine-induced immune response.
If a person is receiving antibody therapies (that aren’t specific to COVID-19) then receipt of a COVID-19 vaccine “either simultaneously with or at any interval before or after receipt of an antibody-containing product is unlikely to substantially impair development of a protective antibody response.”
CDC guidelines if a person who is vaccinated later develops COVID-19
If someone receives either the single Jansen dose or the double mRNA doses and then tests positive for SARS-CoV-2, “healthcare providers and local health departments are encouraged to request the specimen be held and to report the case to the state health department.” The CDC will work with the state health department. These scenarios should also be documented in VAERS.
Vaccinating people with a known COVID-19 exposure or during COVID-19 outbreaks
“COVID-19 vaccines are not currently recommended for outbreak management or for post-exposure prophylaxis to prevent SARS-CoV-2 infection in a person with a known exposure. Because the median incubation period of COVID-19 is 4–5 days, it is unlikely that a dose of COVID-19 vaccine would provide an adequate immune response within the incubation period for effective post-exposure prophylaxis.”
As a general guiding principle, if someone is in quarantine due to an exposure to COVID-19, they should refrain from a vaccination visit – because they may expose healthcare workers and other people during the visit. The principle also applies if a person has a known COVID-19 exposure after their first visit and before a second visit.
People with known COVID-19 exposures in a long-term care facility, a homeless shelter, or a correctional facility – may be vaccinated. This is because exposure to and transmission of the disease can occur over a long time period and because healthcare workers are already in close contact with the residents.
“People residing in congregate settings (healthcare and non-healthcare) who have had an exposure and are awaiting SARS-CoV-2 testing results may be vaccinated if they do not have symptoms consistent with COVID-19. Vaccinators should employ appropriate infection prevention and control procedures.”
How should COVID-19 vaccination symptoms be handled?
It’s possible that receiving a COVID-19 vaccine dose could create symptoms. The CDC states that for all three approved vaccines, patients can take i – if medically appropriate. The CDC does not recommend using these medications proactively – to prevent post-vaccination symptoms – because there’s not any available information on the impact of such medication on “COVID-19 vaccine-induced antibody responses.”
So far, the reporting of anaphylactic reactions following the taking of a COVID-19 vaccine is rare. The CDC does not recommend taking antihistamines before a vaccination to prevent an allergic reaction.
“Infection prevention and control considerations are available for healthcare personnel and long-term care facility residents with systemic signs and symptoms following COVID-19 vaccination.”
The CDC guidance on the three approved vaccines for COVID-19 includes principles for the timing of the vaccines, who should obtain the vaccine, whether people who have already had COVID-19 should receive a vaccination, whether children should receive a vaccine, and other issues. These guidelines are expected to change as new vaccines hopefully become available.
Doctors and medical practices should contact Cohen Healthcare Law Group, PC to discuss HIPAA and other laws that affect vaccination and other health records. Our experienced healthcare attorneys help healthcare providers establish HIPAA compliance protocols.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
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