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Johnson & Johnson’s experimental COVID-19 vaccine was 72 percent effective at preventing moderate and severe disease in the United States and 85 percent effective at preventing severe disease globally. But the one-shot vaccine struggled to fight off emerging virus variants in other countries, lowering its overall efficacy to 66 percent.

The topline results from Johnson & Johnson’s Phase III ENSEMBLE trial , announced Friday, suggest the vaccine will be yet another much-needed weapon against the pandemic virus, which has now infected over 100 million worldwide and killed nearly 2.2 million.

“Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible,” said Mathai Mammen, global head of research and development at Janssen Pharmaceutical (owned by J&J). “The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.”

Enlarge / A registered nurse practitioner holds up a sign and a flag asking for another patient to dose with the Pfizer Covid-19 vaccine as well as a more vaccine doses at a vaccination site in Seattle, Washington on January 24, 2021. (credit: Getty | Grant Hendsley )

With the country’s vaccine rollout in utter disorder, health officials in the Biden administration are cautiously trying to both manage expectations and express optimism.

In a series of interviews over the weekend, officials warned that states could face vaccine shortages in the short term, with some states’ supplies already running low—or completely running out. On the other hand, the officials remained convinced that they would be able to achieve the administration’s goal of getting 100 million doses in arms in their first 100 days in office—a goal that has been criticized as being both too ambitious and not ambitious enough.

With 95 days to go until their goal’s deadline, the officials have made clear just how much work they face in getting vaccinations on track.

Enlarge / President-elect Joe Biden delivers remarks January 07, 2021 in Wilmington, Delaware. (credit: Getty | Chip Somodevilla )

President-elect Joe Biden is reportedly planning to ditch the current Trump Administration policy of withholding half of all available COVID-19 doses to ensure that the requisite second doses are available, according to a report by CNN .

Instead, the incoming administration plans to release the full available supply to states and jurisdictions.

"The President-elect believes we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible. He supports releasing available doses immediately and believes the government should stop holding back vaccine supply so we can get more shots in Americans' arms now," TJ Ducklo, a spokesman for Biden's transition told CNN. "He will share additional details next week on how his administration will begin releasing available doses when he assumes office on January 20th."

Enlarge / COVID-vaccine-maker Moderna (right), has been placed in the ranks of Martin Shkreli (left). (credit: Drew Angerer / Florian Gaertner / Getty Images)

One of the leading developers of COVID-19 vaccines has now been placed in the ranks of people like Martin Shkreli—the disgraced pharmaceutical executive infamous for jacking up the price of an old, life-saving drug by more than 5,000 percent. He is now serving an 84-month prison sentence from a 2017 conviction on fraud counts unrelated to the drug pricing.

Moderna, maker of one of only two vaccines granted emergency authorizations to prevent COVID-19 in the US, has been shamed with a 2020 “Shkreli Award” by the Lown Institute, a healthcare think tank. The awards, announced annually for four years now, go to “perpetrators of the ten most egregious examples of profiteering and dysfunction in health care.”

Award judges cited Moderna’s pricing of its COVID-19 vaccine, which was developed with $1 billion in federal funding. Still, despite the tax-payer backing, Moderna set the estimated prices for its vaccine significantly higher than other vaccine developers.

Enlarge / Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, receives the Moderna Inc. COVID-19 vaccine during an event at the NIH Clinical Center Masur Auditorium in Bethesda, Maryland, on Tuesday, Dec. 22, 2020. (credit: Getty | Bloomberg )

The country’s top infectious disease expert, Anthony Fauci, received his first dose of Moderna’s mRNA COVID-19 vaccine during a livestreamed event Tuesday at the National Institutes of Health.

Fauci, who will turn 80 this December 24, has been the country’s steady public health advisor throughout the pandemic, and many people have hinged their acceptance of any vaccine on Fauci’s personal approval.

The esteemed doctor is also director of the NIH’s National Institute of Allergies and Infectious Diseases, which co-developed the vaccine with Moderna.

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Late Friday, the Food and Drug Administration issued an emergency authorization to a COVID-19 vaccine from a company called Moderna. The move follows an enthusiastic endorsement of the vaccine following an evaluation of clinical trial data by the FDA's Vaccines and Related Biological Products Advisory Committee. Moderna already has millions of doses prepared, and the federal government has pre-issued a large order for more, which will enable more extensive vaccinations than would be possible previously, where the agency had only issued an authorization to the Pfizer/BioNTech vaccine .

The authorization was considered to be a matter of time following the release of safety and efficacy data from a large clinical trial that had enrolled over 30,000 people. Emergency Use Authorizations require that a product or treatment meet a number of criteria, including the declaration of a medical emergency, which was done earlier this year, and the lack of an FDA approved alternative. (FDA approval is distinct from an Emergency Use Authorization, so the authorization of the Pfizer/BioNTech vaccine isn't a barrier to further authorizations.)

Beyond that, the product must be considered likely to be effective, and its potential benefits need to outweigh its potential risks. The votes from the members of the Vaccine Advisory Committee were unanimous that the benefits outweighed the risks, a conclusion that was well supported by the clinical trial data. That cleared the way for Friday's Authorization, which took place on a similar schedule to the authorization of the Pfizer/BioNTech vaccine the week prior.

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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 / Stephen Hahn, commissioner of the US Food and Drug Administration. (credit: Getty | Bloomberg )

11:25 pm EST Update: The US Food and Drug Administration has issued an emergency use authorization for the COVID-19 vaccine developed by Pfizer and BioNTech.

In a late-night statement , Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, said:

“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States... With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks.

The announcement comes just hours after reports that the Trump administration pressured the agency and reportedly threatened FDA commissioner Stephen Hahn to finalize the authorization Friday. The FDA announced Friday morning that it was "rapidly" working to finalize the issuance, which was initially expected Saturday.

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.