Agency’s sudden change of attitude questions effectiveness of Oxford vaccine from outdated information

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) pointed out Tuesday that the efficacy data of the Oxford vaccine (jointly developed by Oxford University and AstraZeneca Pharmaceuticals), which was tested on a large scale in the Americas by the British pharmaceutical company AstraZeneca, may have used “outdated information”, so that the information may be incomplete. This statement made the Oxford vaccine, which was earlier caught in the blood clot doubt, suffer another setback.

AstraZeneca said only on Monday that the Oxford vaccine had proved to be 79 percent protective against symptomatic infections and 100 percent protective against severe and hospitalized symptoms after large-scale trials in the United States, Chile and Peru. However, the National Institute of Allergy and Infectious Diseases said yesterday that the Data Safety Monitoring Board (DSMB) expressed concern that AstraZeneca’s trial results may have used “outdated information” and that the efficacy information provided may be incomplete. The Institute added: “We urge the company to work with the DSMB to review the efficacy information and ensure that the most correct and up-to-date efficacy information is available as soon as possible.”

The Institute said that the FDA and CDC will make a decision on the authorization of the Oxford vaccine for use in the United States only after a thorough review of the information by an independent advisory committee. Outsiders questioned that the matter could throw a wrench in AstraZeneca’s plans to seek U.S. authorization for emergency use of the Oxford vaccine.