Enlarge / A picture taken on January 15, 2021 shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit: Getty | JEAN-FRANCOIS MONIER )

In a bit of good news, Pfizer and BioNTech announced today that their highly effective COVID-19 vaccine does not require ultra-cold storage conditions after all and can be kept stable at standard freezer temperatures for two weeks.

The companies have submitted data to the US Food and Drug Administration demonstrating the warmer stability in a bid for regulatory approval to relax storage requirements and labeling for the vaccine.

If the FDA greenlights the change, the warmer storage conditions could dramatically ease vaccine distribution, allowing doses to be sent to non-specialized vaccine administration sites. The change would also make it much easier to distribute the vaccine to low-income countries.

Enlarge (credit: Getty | Congressional Quarterly )

With concerning coronavirus variants erupting around the world, the US Food and Drug Administration is ironing out how to rapidly review vaccine tweaks that better protect against the mutants—and the regulatory agency is turning to its experience with annual flu shots to do so.

In a statement late Thursday, the regulatory agency said it is actively hashing out what kind of “streamlined” clinical data makers of authorized COVID-19 vaccines could submit. The agency expects to have a draft of its guidance in the next few weeks.

The announcement suggests that makers of authorized vaccines will not be required to submit reams of data from large, months-long clinical trials, as they did for their initial authorizations. Still, data on any altered vaccine—however pared down—would still have to be enough to convince FDA scientists that a next-generation shot is safe and effective against variants. Vaccine alterations may include changes to the initial vaccine design or additions of new vaccine components, the FDA said.

Enlarge / The head office of Janssen pharmaceutical company on February 5, 2021 in Leiden, the Netherlands. The American mother company of Janssen, Johnson & Johnson, has requested quick approval in the United States for the coronavirus vaccine that was developed by Janssen Vaccines in Leiden. (credit: Getty | BSR Agency )

Johnson & Johnson on Thursday announced it has applied to the US Food and Drug Administration for an Emergency Use Authorization for its one-shot COVID-19 vaccine.

If the EUA is granted, the vaccine will be the third authorized for use in the US against the pandemic coronavirus, likely boosting the vaccine supply in the coming months and helping to hasten immunization country-wide.

J&J’s application to the FDA comes just a week after the company revealed top-line results of its Phase III clinical trial , which found the vaccine to be 66 percent effective overall at preventing moderate and severe COVID-19. J&J’s vaccine—made by its vaccine developer Janssen Pharmaceuticals—was 85 percent effective at preventing severe disease. In the trial, severe disease was defined as testing positive for the virus as well as having signs consistent with severe systemic illness, respiratory failure, shock, or organ failure, or being admitted to an intensive care unit, or dying. The company reported that no one who received the vaccine was hospitalized or died during the trial.

Enlarge / Hand sanitizer being applied to a person's hand. (credit: Getty | Leopoldo Smith )

The US Food and Drug Administration on Monday issued a first-of-its-kind alert to try to block the import of toxic hand sanitizers from Mexico, which have been flooding the market amid the COVID-19 pandemic.

Last June, the regulatory agency began issuing alerts and warnings for consumers about dangerous and counterfeit hand sanitizers, many of which were made in Mexico. Since then, the FDA has issued alerts on 226 products . An FDA survey conducted between April and December found that 84 percent of products tested from Mexico were not in compliance with FDA regulations.

Many of the concerning products are labeled as containing safe alcohols but actually contained methanol, an extremely poisonous form of alcohol associated with incorrectly distilled liquors that can cause blindness and even death. The FDA discovered some other products containing another toxic ingredient, 1-propanol , while others simply contained insufficient amounts of safe alcohols for sanitation. (Safe alcohols for hand sanitizers include ethanol, aka ethyl alcohol, at concentrations above 60 percent or isopropyl alcohol at concentrations above 70 percent).

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 (credit: DeFodi Images )

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.

Enlarge / This unassuming building in Massachusetts has taken on remarkable significance in recent weeks. (credit: JOSEPH PREZIOSO / Getty Images )

Earlier this week, the FDA released documents that summarized the data on a second SARS-CoV-2 vaccine candidate, this one from a company called Moderna. That document was the background for a meeting of the FDA's Vaccines and Related Biological Products Advisory Committee, which would consider whether the benefits of the vaccine outweigh its potential risks. That question is one of the key considerations for the agency as it decides whether to grant an emergency use authorization similar to the one it gave the Pfizer/BioNTech vaccine .

After an all-day meeting that frequently focused on other topics, the committee was near unanimous: 20 votes for approval, none against, and one abstention.

Emergency use authorizations have a number of requirements once a health emergency hsa been declared. There must be no alternatives that have achieved full FDA approval, there must be reasons to think that the treatment will be effective, and its benefits are considered likely to outweigh its risks. It's that final question—the risk vs. benefit balance—that the advisory committee was called to address.

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.