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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

Nevada health officials are sending a message to federal agencies allocating COVID-19 vaccines to states: Show us your math...Questions have dogged state officials since Centers for Disease Control and Prevention data showed Nevada consistently ranking near the bottom of national lists for both receiving vaccine doses and putting shots into arms...Each state’s vaccine allocation is purportedly proportional to its adult population, but officials have offered conflicting information on what year’s population numbers are being used...READ MORE

Pfizer and Moderna have agreed to deliver another 200 million COVID-19 vaccine doses to the U.S., bringing the total on tap to 600 million, or enough to vaccinate 300 million people...President Joe Biden announced the pending deals on Tuesday, noting the extra doses would be delivered this summer. Moderna confirmed the negotiations in a press release...although it said the discussions are for “delivery in the third quarter of 2021.” Pfizer also confirmed the negotiations but didn't specify the timing...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

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

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

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

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

A new national consortium of virologists has been set up to systematically assess how mutations in SARS-CoV-2 affect key outcomes such as effectiveness of vaccines and therapies, transmissibility of the virus and the severity of COVID-19 infections...Now is the critical time to do this, as the level of both natural and vaccine-conferred immunity that might drive natural selection is increasing, said Wendy Barclay, head of the department of infectious disease at Imperial College London, who is leading the G2P-UK (Genotype to Phenotype-UK) project...“The virus has circulated in humans for more than a year; we’re in a phase where the virus is constantly throwing up new variants and we need to gear up to assess the risk they pose, and to understand the mechanisms by which they act,” Barclay said...READ MORE

A special fund for vaccine research that was set aside by the U.S. Department of Health and Human Services in 2010 has been misused to pay for unrelated expenses, a government report shows...In a letter to newly-inaugurated President Joe Biden and Congress, the U.S. Office of Special Counsel said millions of dollars intended to be used to bolster preparedness for public health emergencies such as the ongoing COVID-19 pandemic and other potential viral outbreaks, have been flagrantly misused to finance other expenses...READ MORE