Coronavirus updates: 1st vaccines now on the way to all 50 US states

Scientists from the U.S. Food and Drug Administration on Tuesday appeared set to confirm that the Pfizer/BioNTech COVID-19 vaccine is safe and effective against the virus, according to documents released ahead of a crucial meeting on the vaccine this week.

According to a document prepared by FDA staff, government scientists plan to tell the advisory committee that the data is adequate to determine the vaccine is both safe and effective.

While that doesn't mean the FDA is prepared to authorize it just yet, the briefing materials suggest agency staff aren't warning of any last-minute issues.

"Safety data from approximately 38,000 participants [greater than or equal to] 16 years of age randomized 1:1 to vaccine or placebo with a median of 2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA," the FDA wrote.

The report notes the most common reaction was a skin reaction at the injection site, followed by fatigue or headaches.

The FDA released data on the Pfizer/BioNTech vaccine trials and the agency's scientific analysis ahead of an advisory committee meeting on Thursday, when independent experts are set to discuss and vote on whether to recommend the vaccine be authorized for emergency use.

ABC News' Stephanie Ebbs and Anne Flaherty contributed to this report.

The chief science adviser to Operation Warp Speed, the U.S. government's initiative to expedite vaccine development, said he doesn't know what vaccine-related executive order President Donald Trump is expected to sign on Tuesday.

"Frankly, I don't know and, frankly, I'm staying out of this. I can't comment," Dr. Moncef Slaoui told ABC News chief anchor George Stephanopoulos in an interview Tuesday on "Good Morning America."

When pressed on the matter, Slaoui added: "Our work is, you know, rolling. We have plans. We feel that we can deliver the vaccines as needed, so I don't exactly [know] what this order is about."

Trump is expected to discuss the order at a COVID-19 vaccine summit to be held at the White House later Tuesday, multiple White House officials told reporters during a background briefing on Monday evening. While it's not entirely clear on how exactly the order would work, the move is designed to prevent the U.S. government from shipping any vaccine doses it has purchased to aid foreign countries until all the needs within the United States are met.

White House officials also denied reports that the Trump administration turned down an offer last summer to purchase an additional 400 million doses of a COVID-19 vaccine developed by U.S. pharmaceutical giant Pfizer and its German partner BioNTech, and that the companies now may not be able to provide more of their vaccine to the United States until June 2021 because they have committed those doses to other countries.

When asked about the matter, Slaoui explained Operation Warp Speed's strategy in securing vaccine doses.

"We selected six different vaccines to build a portfolio to manage the risk that some may work and some may not work, but also to ensure that as more than one would work that we would accumulate vaccine doses from this portfolio of vaccines," he said. "If somebody came to us and said, let's buy more of this vaccine or that vaccine, no one reasonably would buy more from any one of those vaccines because we didn't know which one would work and which one may be better than the other. Once the vaccine's performance becomes known is the right time, given the strategy we've taken, to go and order more vaccine doses, which we may be doing. And frankly, the constructive thing to do if one of the suppliers has challenges producing enough vaccine doses is to roll our sleeves and help ensure that capacity can be increased."

Slaoui said he's confident the U.S. government will be getting vaccines to Americans who need them "as soon as possible" and that plans are "still on track."

"We will work with Pfizer to try and increase capacity and have those vaccines available," he said. "We have two more vaccines from J&J and AstraZeneca that will be completing their Phase 3 trials in January and most likely, I hope, be approved for use in February. We have tens of millions of doses from those vaccines, you know, participating to the volume of vaccines we need to immunize the U.S. population as we promised, all of it by the middle of the year 2021 and that's still on track."

Slaoui said Operation Warp Speed has a meeting with President-elect Joe Biden's transition team scheduled for Thursday.

"We look forward to, you know, sharing all the information and working together," he said. "Our objective has always been outside of politics and making sure we make available these vaccines for the U.S. people, and that's what we're doing."

ABC News' Ben Gittleson, John Parkinson and Eric Strauss contributed to this report.

As COVID-19 vaccinations were administered to high-risk groups of people across the United Kingdom on Tuesday, Prime Minister Boris Johnson warned that the nation "can't afford to relax now."

"It is important for people to understand that the virus is alas still rising in some parts of the country," Johnson said while visiting a newly-opened vaccination center in London.

When asked whether he would be receiving the shot, Johnson told reporters he is "not in the priority group" outlined by the government but that those who are eligible should get it.

"I would just say to all those who are scared, don't be," he said. "You see people take the vaccine this morning, in large numbers, people are going to be taking it in the next few days and weeks and there is nothing to be nervous about."

The United Kingdom -- made up of England, Scotland, Wales and Northern Ireland -- has the seventh-highest tally of COVID-19 infections in the world, with more than 1.7 million confirmed cases, including over 61,000 deaths, according to a real-time count kept by Johns Hopkins University. The European island nation launched a mass immunization program on Tuesday, after authorizing emergency use of a COVID-19 vaccine developed by U.S. pharmaceutical giant Pfizer and its German partner BioNTech.

There were 192,299 new cases of COVID-19 confirmed in the United States on Monday, according to a real-time count kept by Johns Hopkins University.

It's the 35th straight day that the U.S. has reported over 100,000 newly diagnosed infections. Monday's tally is less than the country's all-time high of 227,885 new cases confirmed on Dec. 4, according to Johns Hopkins data.

An additional 1,404 deaths from the disease were also registered nationwide on Monday, down from a peak of 2,879 fatalities on Dec. 3, according to Johns Hopkins data.

COVID-19 data may be skewed due to possible lags in reporting over Thanksgiving followed by a potentially very large backlog from the holiday.

A total of 14,954,331 people in the U.S. have been diagnosed with COVID-19 since the pandemic began, and at least 283,746 of them have died, according to Johns Hopkins data. The cases include people from all 50 U.S. states, Washington, D.C., and other U.S. territories as well as repatriated citizens.

Much of the country was under lockdown by the end of March as the first wave of pandemic hit. By May 20, all U.S. states had begun lifting stay-at-home orders and other restrictions put in place to curb the spread of the novel coronavirus. The day-to-day increase in the country's cases then hovered around 20,000 for a couple of weeks before shooting back up over the summer.

The numbers lingered around 40,000 to 50,000 from mid-August through early October before surging again to record levels, crossing 100,000 for the first time on Nov. 4 and reaching 200,000 for the first time on Nov. 27.