Pharmacies Having to Take Extra Steps to Provide ‘Booster’ COVID-19 Vaccines
Providing “booster” shots of COVID-19 vaccine likely will require more paperwork at pharmacies providing them. One large chain says it will mandate that patients bring vaccination records and attest that they meet the requirements related to being immunocompromised, based on FDA action, before they can get a third jab. Here is more information.
WASHINGTON, DC – Pharmacists who offer COVID-19 vaccination are once again being put into potentially fraught situations with Food and Drug Administration authorization for a third “booster” dose in certain patients.
What makes it difficult is determining who is eligible under the amendment to the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine. The FDA says it made the changes to allow for the use of an additional dose in certain immunocompromised individuals, specifically solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Even if the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices offers further clinical recommendations regarding immunocompromised individuals, the issue of documentation remains.
In announcing that select pharmacies now would administer an additional dose of Pfizer and Moderna COVID-19 vaccine to certain immunocompromised individuals, Walgreens said patients would be required to bring their vaccination records to appointments and also must attest to their eligibility.
The drugstore chain says, based on the FDA action, it would make booster shots available for those who are moderately to severely immunocompromised including people undergoing cancer treatment, stem cell or organ transplant recipients, people living with HIV or those who are receiving immunosuppressive treatments.
“Walgreens is committed to administering COVID-19 vaccines to our most vulnerable populations as quickly and safely as possible,” Kevin Ban, MD, Walgreens Chief Medical Officer said in a press release. “As one of the first companies to begin providing these vaccines, we have an experienced team of pharmacists and technicians, as well as the infrastructure to support the increased demand for these vaccines.”
CVS Health also says it will provide the third vaccine doses in certain situations.
Despite the recent actions by the FDA and the limitations it set forth, the CDC estimates that more than a million Americans have received the Moderna or Pfizer vaccine have gone back for an unauthorized third booster shot, according to an internal CDC briefing document obtained by ABC News. Even with its recent EUA expansion, the FDA is not recommending booster shots for people who are not immunocompromised.
The news organization said that, based on their review of the document, Florida is among the states reporting the highest number of people receiving booster shots, followed by Ohio, California, Illinois and Tennessee.
The report also adds that the estimated 1.1 million recipients discussed in the memo are likely undercounted because it does not include information on those who received the single dose Johnson & Johnson vaccine and then obtained a second shot.