FDA Approves Syringes to Extract Additional Dose of COVID-19 Vaccine

With the news that the Pfizer and BioNtech can give COVID-19 vaccine vials an extra dose, the federal agency has updated the labeling to allow the use of low dead volume syringes to extract it.

The United States Food and Drug Administration (FDA) has approved an updated label that allows a potential additional dose of the Pfizer and BioNtech COVID-19 vaccine to be extracted using low dead volume syringes, as reported on CNN.

“Low dead volume syringes and / or needles can be used to extract six doses from a single vial. If standard syringes and needles are used, there may not be enough volume to extract a sixth dose from a single vial” , the FDA said. .

While the Pfizer and BioNtech overfill COVID-19 vaccine vials may provide an additional dose, low dead volume syringes are not standard and many hospitals, medical centers and vaccine distribution sites may not have access to them at this time. to. .

In recent days, it has been reported that Pfizer plans to count the additional doses towards its commitment of 200 million doses distributed to the US by the end of July this year.

This decision, initially in a story in the The New York Times, comes at a time when vaccine supplies are badly needed and vaccine roll-out is slower than expected. And some health care providers say the extra doses are not consistent with each vial.

In the same story, it was also reported that Pfizer executives are challenging the Emergency Use Authorization formulation of the vaccine to recognize that distributed vials contain 6 doses, not 5. The difference, recognized by the FDA on Jan. 6, affects the contract of pharmaceutical company with the US government.

This may also make it challenging for the new administration to meet its vaccination goal. President Joe Biden has set a goal to deliver 100 million doses of the vaccine in the first 100 days of his administration.

.Source