Pfizer Ships Fewer Covid Vials to US After Changing FDA Label

Some syringes distributed by the federal government are not effective enough to withdraw the sixth dose, resulting in hospitals injecting valuable vaccine. Earlier this month, officials from Operation Warp Speed, the Trump administration’s vaccination accelerator, acknowledged the problem and said the federal government was “rapidly” evaluating options “to reintroduce the vaccination kits sent to suppliers.

Pfizer says the change to the label was made to “give healthcare providers clarity, minimize vaccine wastage and use the vaccine efficiently.”

The FDA told POLITICO that before making the label change at Pfizer’s request, it was considering the availability of low-dead volume syringes – the type needed to withdraw the extra dose – and changes already being made by the World Health Organization and the European Medicines agency has been set up to allow the use of the extra liquid.

“By far the most important, [FDA considered] ‘the need to ensure that the maximum number of individuals are vaccinated as quickly as possible in the United States, as the use of 6 doses from the vials will vaccinate 16.6 percent more Americans than five doses would do,’ ‘a spokesman said. said.

But without enough specialized syringes, Pfizer’s decision likely means the US will have less usable doses than they expected.

The FDA label change is the latest twist in a troubled implementation that sees vaccinations far lagging behind the targets set by the Trump administration.

President Joe Biden this week signed executive orders invoking the Defense Production Act, in an effort to speed up the availability of certain supplies. According to a White House official, agencies are seeing a shortage of supplies, such as the lack of efficient sprayers. However, it is unclear when production will increase.

The Centers for Disease Control shocked some government officials Thursday when the agency indicated that Pfizer’s vampires would count for vaccination at six doses, according to an email from the agency that POLITICO received. The CDC said it would increase the number of syringes it sends with the vaccine, but that it may not be the “low-dead-volume” type that can extract the extra doses.

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