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New coronavirus variants have prompted COVID-19 vaccine makers to start developing updates to their existing offerings. To speed their journey to a pandemic-fatigued public, the FDA says it’s developing expedited review rules for the follow-up shots...The FDA’s working on guidance for the types of data needed to support changes to COVID-19 vaccines. The new rules would provide for “streamlined clinical programs” that can demonstrate an immune response to new variants and “can be executed quickly,” FDA’s acting commissioner, Janet Woodcock, said in a statement...READ MORE

The data is continuing to come in on the various COVID-19 variants, and so far the news is pretty good. Pfizer and BioNTech announced that their COVID-19 vaccine appears effective against an engineered virus developed with three key mutations found in the South African variant. This was conducted in a laboratory test by Pfizer and the University of Texas Medical Branch...the data has not yet been peer-reviewed, it demonstrated a less than two-fold decrease in antibody titer levels. The bottom line is that the Pfizer-BioNTech vaccine is likely effective in neutralizing the E484K and N501Y mutations found in the South African variant...READ MORE

Merck announced that it is going to stop developing its two COVID-19 vaccine candidates, dubbed V590 and V591, after poor responses in Phase I trials. They are shifting their attention to advancing two therapeutic drugs for COVID-19, MK-4482 and MK-7110...“We are grateful to our collaborators who worked with us on these vaccine candidates and to the volunteers in the trials,” said Dean Y. Li, president, Merck Research Laboratories. “We are resolute in our commitment to contribute to the global effort to relieve the burden of this pandemic on patients, health care systems and communities.”...READ MORE

Unlike his predecessor, President Biden is embracing a more centralized strategy for managing the COVID-19 pandemic. He signed a flurry of executive orders and presidential directives on January 21, including one that institutes new mask mandates for interstate travel, one that creates a national board to expand access to testing, and another that requires international visitors to quarantine upon arrival in the United States. Biden pitched his National Strategy for the COVID-19 Response and Pandemic Preparedness as a "wartime effort" and did not soft-pedal the grim details...READ MORE

With Novavax and Johnson & Johnson data now in hand, the world has efficacy numbers on at least five COVID-19 vaccine programs. That's plenty for analysts to parse—and they're busy doing not only that, but also sizing up the market as the field of top players grows...The upshot? Blockbuster sales to go around, but Pfizer and Moderna will continue to lead the pack, partly thanks to their ability to quickly deploy mRNA against new variants. And for Moderna, at least, that means almost $14 billion in projected sales just this year from one team of analysts...READ MORE

Within days of AstraZeneca's surprise cut to first-quarter COVID-19 vaccine deliveries to Europe, a fierce debate between the drugmaker and government officials is playing out behind the scenes—and in the press...CEO Pascal Soriot said the company has no legal obligation to deliver vaccines on a specific timeline. The EU maintains AZ’s new delivery schedule is “not acceptable.”...The sides were set to meet Wednesday, but an EU official told Politico the drugmaker had pulled out. AstraZeneca told Fierce Pharma via email it hadn't...READ MORE

Gov. Steve Sisolak has asked the U.S. Department of Health and Human Services to look into why Nevada is near the bottom of the list for the amount of COVID-19 vaccine it has been allocated per capita...“We need our fair share of vaccine doses to stand up and sustain successful vaccination efforts to reach Nevadans in an equitable fashion,” Sisolak wrote in a letter to acting Health and Human Services Secretary Norris Cochran, according to a news release on Monday. “Through this letter I am asking the U.S. Department of Health and Human Services to look into why Nevada is so low on the allocation list, and more important, to find ways to increase our allocation both immediately and for the long term.”...READ MORE

Scientists gave Russia’s Sputnik V vaccine the green light...saying it was almost 92% effective in fighting COVID-19 based on peer-reviewed late-stage trial results published in The Lancet international medical journal...The results, collated by the Gamaleya Institute in Moscow that developed and tested the vaccine, were in line with efficacy data reported at earlier stages of the trial, which has been running in Moscow since September...READ MORE

Moderna announced it has started development on a booster to its COVID-19 vaccine, which the company hopes will work against the recently discovered (and more transmissible) SARS-CoV-2 variant from South Africa...Moderna’s COVID-19 vaccine mRNA-1273 appears to be effective for protecting against B.1.1.7 and B.1.351, two highly infectious strains first discovered in the U.K. and South Africa, respectively...The South African B.1.351 variant features ten mutations found in the spike protein of SARS-CoV-2, the novel coronavirus responsible for COVID-19. Variants from both the U.K. and South Africa have spread quickly across the globe, with some data suggesting these variants are associated with increased transmission and greater post-infection viral burden...READ MORE

The COVID-19 pandemic has raised the profile of mRNA vaccines in a dramatic way in about a year. Looking forward, the technology holds more promise and could displace traditional shots in some diseases, experts said, but it's not time to give up on well-known vaccine platforms, either...researchers at Moderna...reached human testing for their mRNA vaccine in record time. And separately, in under a year of development, testing and manufacturing, Pfizer and its mRNA partner BioNTech were able to score an FDA emergency use authorization last December...In addition to being able to rapidly advance new vaccines in response to emerging threats, the “beauty” of the platform is that the production process is “universal,"...Still, it’s not time to go all-in on mRNA... While experts are clearly enthusiastic about the platform, that “doesn’t guarantee that mRNA will immediately work against all pathogens,"...READ MORE