Vaccine data set to be crunched

FDA advisory team expected to give US verdict on Pfizer candidate in days

As the United States struggled with more than 20,000 coronavirus patients in intensive care, there is hope that regulators will give emergency authorization to a vaccine from Pfizer on Thursday. Such a move by the Food and Drug Administration, or FDA, would clear the way for its almost-immediate distribution to all 50 states.

On Tuesday, the FDA released its evaluation of the safety and effectiveness data for the vaccine, on which Pfizer partnered with BioNTech. The agency said the data was in line with its guidance on emergency use authorization, according to Reuters.

On Thursday, the agency's vaccine advisory committee of independent experts will meet. They will debate that data and whether the FDA should clear the vaccine. That will be an open meeting, which includes time for members of the general public to speak, as part of the FDA's effort to be transparent in convincing people to take the vaccine.

If the advisory committee votes "yes", the agency is expected to authorize the vaccine within days. Operation Warp Speed, a White House-led initiative to develop and distribute vaccines, has said it plans to begin shipping the vaccine within 24 hours of FDA approval.

On Dec 15, the agency will post its views of Moderna's vaccine, in preparation for an advisory committee two days later.

The Washington Post reported on Monday that Pfizer has told the administration of US President Donald Trump it can't provide substantial additional doses of its vaccine until late June or July because other countries have bought up most of its supply, according to multiple individuals familiar with the situation.

Last summer, Pfizer officials had urged the US to initially purchase 200 million doses, or enough for its two-shot regimen for 100 million people, according to people knowledgeable about the issue who spoke on the condition of anonymity because they weren't authorized to discuss the situation. But officials declined, choosing instead the 100 million doses, or enough for 50 million people, they said.

In a statement, Pfizer said that "the company is not able to comment on any confidential discussions that may be taking place with the US government".

Officials from the Trump administration denied there would be availability issues in the second quarter, pointing to other vaccines in the pipeline, but others said problems are possible, according to the Post.

Fox News reported late on Monday that Trump was expected to sign an executive order during a "COVID-19 Summit" at the White House on Tuesday that would ensure all US citizens have access to a COVID-19 vaccine before the US government begins helping nations around the world.

The White House said it is inviting governors, federal officials and executives of pharmaceutical companies and drugstore chains to attend.

Christmas concern

Anthony Fauci, the nation's top infectious diseases expert, on Monday warned that the Christmas holiday season may be even worse than Thanksgiving in terms of spreading the coronavirus. Millions of people rejected warnings from health officials and traveled for the long holiday weekend. He said the US is "probably just at the beginning" of seeing the resulting increase in cases.

The US crossed the threshold of 20,000 COVID-19 patients in intensive care beds on Sunday, according to the COVID Tracking Project. The country reported 158,715 new infections on Monday.

On Monday, New York City reopened elementary grades at its public schools after closing them last month when the virus-test positivity rate surpassed a limit set by the mayor.

Of the nation's 75 largest public school districts, 18 have gone back to remote learning in the past month, according to data compiled by the Council of the Great City Schools, The Wall Street Journal reported.