FDA approves H1N1 vaccine, affects NY flu shot requirements

By: Evan Sweeney September 16th, 2009

Yesterday, the FDA announced their approval of the 2009 H1N1 vaccine and expects initial lots to become available for national distribution within the next four weeks. As we talked about yesterday, the vaccine will consist of one shot, not two.

While this may affect many hospital policies, it will assuredly affect healthcare workers in New York. The recent emergency regulation requires healthcare workers in New York State to receive the flu shot by November 30 as a condition of employment.

According to New York State Department of Health (DOH) spokesperson Claire Pospisil, the regulation does include the H1N1 vaccine once it is cleared by the FDA. This is verified in a “Dear Administrator” letter posted on the DOH Web site.

Currently, if employees choose not to get vaccinated by November 30, “they will not be allowed to participate in direct patient care,” Pospisil says. She said yesterday that as of now the November 30 deadline will be enforced for H1N1 vaccinations as well. The DOH has said additional information will soon be available on their public Web site.

“There is extensive information in medical literature about the transmission of flu to patients by healthcare workers,” Pospisil says. “Unvaccinated healthcare workers are a danger to their patients. Patients in hospitals are particularly vulnerable to become infected with the flu because in many cases their immune systems are compromised.”

Nancy Webber, spokesperson for the New York State Nurses Association (NYSNA) says that because the mandate was pushed through as an emergency regulation, NYSNA didn’t get a chance to comment. Furthermore, she says the vaccine is not the ultimate solution.

“It’s not like polio or small pox where you can eradicate a disease through vaccination,” Webber says. “The flu, as you know, mutates constantly so even if you have a flu shot there is no guarantee you are going to be immune from the particular strain that is circulating.”

For now Webber says NYSNA is closely monitoring how hospitals implement this regulation to see if there is any violation of contract agreements.

“We will have to see what disciplinary action they will use and whether we have language in our contract that would protect people, but frankly at this point it’s unknown if a state regulation trumps everything and it might be a legal issue at some point,” Webber says.

However, as of now the regulation is a requirement for this flu season only since emergency regulations in New York expire after 90 days. The DOH is attempting to make it permanent by pushing it through the state regulatory process, according to Pospisil.

“The reason we used an emergency regulation was because with the prospect of both seasonal flu and H1N1 circulating this flu season, we felt we needed to get it immediately in effect,” Pospisil says.

You can read more about the New York regulation in the November issue of Briefings on Infection Control, which will publish in the beginning of October.

For additional information regarding the New York regulation, including exemption and documentation information, refer to the FAQs on the DOH Web site.

Finally, for those healthcare facilities outside of New York that are gearing up for H1N1 vaccinations now that it is FDA approved, you can find a Sample H1N1 Vaccination Distribution Plan in the Tools section.