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As we're waiting for word on the authorization of a second vaccine for use in the US, glitches have been striking the distribution of the first through the federal government's "Operation Warp Speed." This week, the US saw the first use of the vaccine developed by a Pfizer/BioNTech collaboration. But immediately afterwards, many states started saying that orders for shipments in the ensuing weeks were being cut. After some in the federal government had indicated that the problem might be in production, Pfizer issued a statement indicating that it had doses in its warehouse ready to ship out, but no indication of where to ship them too.

All in all, about what you'd expect in the first weeks of a massive undertaking like this.

State of denial

One of the first states to report problems was Illinois, where its governor, J.B. Pritzker, said that it had indications it would only be receiving half the expected doses of the Pfizer/BioNTech vaccine next week. Since then, over a dozen states have indicated that they'll be receiving fewer doses than planned in the second week ( this article seems to have a fairly comprehensive list).

Enlarge / An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS )

The COVID-19 vaccine developed by Pfizer and BioNTech should be granted an Emergency Use Authorization from the US Food and Drug Administration, according to a committee of independent experts advising the agency.

The committee—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—made the recommendation today in a vote of 17 in favor, 4 against, and 1 abstain. Specifically, committee members voted in the affirmative to the question:

Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?

If the FDA follows the recommendation and grants authorization, the vaccine will be widely accessible to people 16 years and older, and distribution of the vaccine will likely begin in the coming days.

Enlarge / Margaret Keenan, 90, who was the first patient in the United Kingdom to receive the first of two doses of the Pfizer-BioNtech Covid-19 vaccine, reacts as she talks with Healthcare assistant Lorraine Hill, while preparing to leave University Hospital Coventry, in Coventry on December 9, 2020, a day after receiving the vaccine. (credit: Johnny Weeks | Getty Images)

People with a significant history of allergies should not receive the Pfizer/BioNTech coronavirus vaccine, the UK medical regulator has said, after two NHS staff experienced an adverse reaction.

June Raine, chief executive for the Medicines and Healthcare products Regulatory Agency (MHRA), told a UK parliamentary committee that the two individuals had the allergic reaction shortly after receiving the vaccine and that the regulator was investigating. Both people had a history of serious allergies and carried adrenalin pens.

“We know from the very extensive clinical trials that this wasn’t a feature but if we need to strengthen our advice . . . we get that advice to the field immediately,” Dr. Raine said.

Enlarge / US President Donald Trump in the Oval Office of the White House in Washington, DC on December 7, 2020. (credit: Getty | Saul Loeb )

The Trump administration will host a “Vaccine Summit” today at the White House. But notably absent from the vaccine-centered event will be any companies that actually make vaccines—including the companies leading the race for a COVID-19 vaccine, Moderna, Pfizer, and Pfizer's partner BioNTech.

The companies reportedly declined to attend or withdrew, which is seen as a snub to lame-duck President Trump. Senior officials for the Trump administration, meanwhile, said the administration decided to go “in a different direction.”

The Trump administration has pitched the unusual event as a way to educate the public about vaccine development, regulatory approval, and distribution processes and to congratulate the many players helping to develop COVID-19 vaccine candidates. The event includes a “fire-side chat” with top vaccine regulator Peter Marks from the Food and Drug Administration. There will also be talks with representatives from FedEx, UPS, McKesson, CVS and Walgreens, who will all help get any FDA-approved vaccines to people’s arms.

Enlarge / An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS )

Pharmaceutical giant Pfizer and German biotech firm BioNTech announced Wednesday that they have wrapped up the Phase III trial of their COVID-19 mRNA vaccine, finding it to be 95 percent effective at preventing disease and consistently effective across age, gender, race, and ethnicity demographics. The vaccine appeared effective at preventing cases of severe disease as well.

The companies added that they have also met a safety milestone—collecting a median of two months of safety monitoring data on trial participants—to file a request for an Emergency Use Authorization (EUA) with the US Food and Drug Administration. They plan to file the request “within days.”

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a statement. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”

Enlarge / Geneva: WHO Director-General Tedros Adhanom Ghebreyesus announced on March 11, 2020 that the new coronavirus outbreak can now be characterized as a pandemic. (credit: Getty | FABRICE COFFRINI )

There’s more good news on the COVID-19 vaccine front today: biotechnology company Moderna reported in a press release this morning that its mRNA vaccine appeared 94.5 percent effective at preventing COVID-19 in an interim analysis of a large, Phase III trial. The news comes exactly one week after similar results came out via press release for another mRNA vaccine developed by pharmaceutical giant Pfizer and German biotech firm BioNTech.

But, while health experts are “cautiously optimistic” for this and many other vaccines in the coming months, they warn that such a timeline will not be fast enough to spare lives and health care systems from the current spike in disease.

“Right now, we are extremely concerned by the surge in cases we’re seeing in some countries,” Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, said in a press conference Monday. “Particularly in Europe and the Americas, health workers and health systems are being pushed to the breaking point.”