> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Feds Discuss Pfizer Vaccine Manufacturing Issues
- URL: https://www.fdaweb.com/feds-discuss-pfizer-vaccine-manufacturing-issues/
- Published: 2020-12-16T12:00:00.000Z
- Updated: 2026-09-14T16:40:22.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5148322

Federal officials told a 10/16 news media call that Pfizer has experienced some unexpected issues in rolling out its Covid-19 vaccine. They reported that at least two trays of vaccine doses delivered to California had to be replaced after their storage temperatures fell below manufacturer requirements, Reuters [reports](https://www.reuters.com/article/health-coronavirus-pfizer-vaccine/top-u-s-health-official-says-pfizer-may-face-challenges-manufacturing-covid-19-vaccine-idUSKBN28Q2AT?ref=fdaweb.com).

Gen. **Gustave Perna** of Operation Warp Speed reported that officials are investigating whether storing the vaccine at a lower-than-expected temperature poses a safety or efficacy risk.

HHS secretary **Alex Azar** reported that Pfizer had reported some manufacturing issues. Reuters said the company did not respond to its request for comment and noted that earlier this week company CEO **Albert Bourla** told CNBC that Pfizer was asking the federal government to use the Defense Production Act to relieve some “critical supply limitations,” particularly in some unnamed components.

The government officials reportedly said they planned to allocate two million doses of the Pfizer vaccine next week and 5.9 million of Moderna’s, assuming it is approved by FDA. They said the government is in talks with Pfizer to secure 100 million additional doses.