U.S. to make millions of bird flu vaccine doses this summer, as cases grow

Around 4.8 million doses of Flu’s vacine are now being prepared for use in response to the growing outbreak of highly pathogenic bird flu, or H5N1, in the U.S., officials say.

The order for doses to be placed in vials comes as the Centers for Disease Control and Prevention is investigating a growing number of human cases linked to the unprecedented outbreak of the virus in dairy cattle this year.

The supplies will be drawn from a “pre-pandemic” stockpile funded by the Federal Strategic Preparedness and Response Administration. Vaccine maker CSL Seqirus was tasked with manufacturing the doses at its North Carolina factory.

“It utilizes a highly scalable production method and is currently positioned to supply up to 150 million doses of influenza vaccine to support an influenza pandemic response within six months of a pandemic declaration,” CSL Seqirus said in a statement. release.

Doses match volume stocks of two main ingredients: an “antigen” targeting the H5 portion of the H5N1 virus with an “adjuvant” designed to enhance the immune response triggered by the vaccine.

Although production of these new bird flu doses is expected to be completed “later this summer,” the vaccines may not yet be immediately ready for use.

“I want to decouple availability and completion from manufacturing, because of course there is that regulatory component that would be necessary to approve or authorize the actual use of the doses,” ASPR’s David Boucher told reporters on Thursday.

The FDA has already approved other vaccines to prepare for potential H5N1 pandemics, including one vaccine by Seqirus. It is unclear when the FDA might grant authorization to release the new injections for use.

“Although the CDC’s current risk assessment for the general public is low, if it is determined that the U.S. population needs to be vaccinated to prevent H5N1 influenza, then the FDA will use its regulatory avenues to take appropriate steps to ensure that vaccines are available in the most timely manner possible,” an FDA spokesperson said in a statement.

Boucher also said that authorities have so far not decided whether to recommend the use of the vaccines. It’s unclear who would be prioritized for the first shots if they were eventually deemed necessary and released to the public.

“If this changes in the future, we would be looking at the population for whom vaccination would be recommended and then making any prioritization decisions at that time,” Boucher said.

A panel of outside CDC vaccine consultants, who have discussed previous pandemic vaccines, are scheduled will meet in June to discuss H5N1 along with routine votes on recommendations for seasonal flu vaccines.

While the C.D.C. it says While the risk from H5N1 to the general public remains low for now, the agency warned that workers in places such as dairy farms and production facilities are now at greater risk of infection and urged the industry to take precautions.

At least three U.S. dairy farm workers have tested positive this year after working directly with infected cows.

O last case in Michigan developed respiratory symptoms, officials announced Thursday, which could make it easier for the virus to spread from person to person.

“Simply put, someone who coughs may be more likely to transmit the virus than someone who has an eye infection like conjunctivitis,” Nirav Shah of the CDC said Thursday.

However, Shah said there is no evidence that person-to-person spread has happened so far. The patient’s contacts so far have not tested positive. Previous Repercussions of H5N1 worldwide, caused by different strains, have also disappeared after limited spread among people.

The CDC is now trying to see whether the strain that infected the last Michigan patient may have developed important mutations that could increase the risk of spread.

“The simple fact that this individual has some respiratory symptoms, once again we should be alert, but in itself is not a reason to change course or suggest that we are at an inflection point,” Shah said.