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 US Food and Drug Administration has authorized the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents between the ages of 12 to 15, the agency announced Monday evening .

In the announcement, acting FDA Commissioner Janet Woodcock called the authorization “a significant step in the fight against the COVID-19 pandemic” that will bring the country “closer to returning to a sense of normalcy and to ending the pandemic.”

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, echoed that sentiment. He called the ability to vaccinate children and teens “a critical step” in the fight against COVID-19.

Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. (credit: Getty | Photonews )

The European Union has declined to renew orders for AstraZeneca’s COVID-19 vaccine, an EU official said Sunday. The decision comes after a series of production and safety troubles with AstraZeneca’s vaccine—and news on Saturday that the EU signed a deal to have Pfizer and BioNTech provide up to 1.8 billion doses of their vaccine between 2021 and 2023.

Last month, the EU took legal action against AstraZeneca, alleging that the company had failed to live up to its contract to supply the bloc with doses. The contract ends in June.

"We did not renew the order after June,” European Internal Market Commissioner Thierry Breton said in a Sunday French radio interview, which was reported by Reuters . “We’ll see what happens," he added, leaving open the possibility of future orders.

Enlarge / US President Joe Biden delivers remarks on the government's pandemic response, including the recently announced partnership between Johnson & Johnson and Merck to produce more Johnson & Johnson vaccine, as US Vice President Kamala Harris (L) looks on at the White House in Washington, DC on March 2, 2021. (credit: Getty | Jim Watson )

With a White House-brokered deal, vaccine giant Merck has agreed to help Johnson & Johnson boost its COVID-19 vaccine production, which is woefully behind on its manufacturing schedule.

President Joe Biden announced today that, with the new deal, the country is on track to have enough COVID-19 vaccine doses to vaccinate every adult in the country by the end of May—two months ahead of earlier plans.

“About three weeks ago, we were able to say that we’ll have enough vaccine supply for adults by the end of July,” the president said in an afternoon address. “And I’m pleased to announce today, as a consequence of the stepped-up process that I’ve ordered and just outlined, this country will have enough vaccine supply—I’ll say it again—for every adult in America by the end of May. By the end of May. That’s progress—important progress.”

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 / Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020. (credit: Getty| NurPhoto )

Dismal preliminary data on AstraZeneca’s COVID-19 vaccine in South Africa—where the B.1.351/ 501Y.V2 coronavirus variant is spreading widely—lead the government there to rethink its vaccination rollout and raised further international concern about the variant .

But the small study has so many limitations and caveats, experts caution that drawing any conclusions from it is difficult.

The study, which has not been published or peer-reviewed but presented in a press conference Sunday , began in June and enrolled only around 2,000 participants, about half of which received a placebo. Early in the study—before B.1.351 emerged—the vaccine appeared over 70 percent effective at preventing mild-to-moderate cases of COVID-19. That is largely in line with the conclusion of an international Phase III trial released by AstraZeneca and vaccine co-developer Oxford University, which showed mixed results for the replication-deficient adenovirus-based vaccine but an overall efficacy of around 70 percent .

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 / The structure of the SARS-CoV-2 spike protein. (credit: University of Arkansas )

Over the summer, you could almost hear a sigh of relief rising from the portion of the research community that was tracking the evolution of the SARS-CoV-2 virus. Viruses, especially those new to their hosts, often pick up mutations that help them adapt to their new habitat, or they evade drugs or immune attacks. But SARS-CoV-2 seemed to be picking up mutations at a relatively sedate pace, in part because its virus-copying enzymes had a feature that lets them correct some errors.

But suddenly, new variants appear to be everywhere , and a number of them appear to increase the threat posed by the virus. A new study helps explain the apparent difference: while new base changes in the virus' genetic material remain rare, some deletions of several bases appear to have evolved multiple times, indicating that evolution was selecting for them. The research team behind this new work found evidence that these changes alter how the immune system can respond to the virus.

This looks familiar

The researchers' interest in deletions started with their involvement with an immunocompromised cancer patient, who held off the infection for over two months without being able to clear the virus. Samples obtained from late in the infection revealed two different virus strains that each had a deletion in the gene encoding the spike protein that SARS-CoV-2 uses to attach to and enter cells.

Enlarge / A vaccine syringe and vial in front of the GSK (GlaxoSmithKline) logo. (credit: Getty | Anadolu Agency )

After its own COVID-19 vaccine setback, GlaxoSmithKline has inked a $180 million deal to help German biotech CureVac manufacture 100 million doses of its mRNA vaccine, which is currently under development. The deal also lays the groundwork for the two to cook up a next-generation vaccine that would protect against several concerning coronavirus variants at the same time.

The partnership is the latest example of a pharmaceutical giant teaming up with a peer—in some cases a rival—to help address the global shortage of desperately needed COVID-19 vaccines.

On January 27, Sanofi—one of the world’s leading vaccine makers—announced that it would use its manufacturing prowess to produce vaccine developed by rivals Pfizer and BioNTech, which has already been authorized for use in the US and the EU. Sanofi will begin producing over 125 million doses of the Pfizer/BioNTech vaccine from its plant in Frankfurt, Germany, later this year.