Regulatory

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80° C and –60° C, according to current CDC guidelines. Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would…

In the early days of the pandemic, hopes were high that a vaccine could return society to normalcy. But now that FDA has authorized two vaccines, much of the general public is waiting for them to become broadly available. Some 4.5% of the U.S. population has been fully vaccinated as of Feb. 17, according to…

Johnson & Johnson (NYSE:JNJ) CEO Alex Gorsky said people may need COVID-19 vaccines annually, like flu shots, over the next several years. Speaking to CNBC, Gorsky cited the mutations and variants of the disease, several of which have already landed in the U.S., as the driving force behind differentiating capabilities of the vaccine to fight off…

Pfizer (NYSE:PFE) is reportedly expecting to trim the time needed to produce COVID-19 vaccine batches to speed up production. The company, which along with BioNTech (NSDQ:BNTX) developed one of two COVID-19 vaccines currently authorized in the U.S., is slated to cut the amount of time it takes to produce a batch of the vaccine from 110 days to…

Eli Lilly (NYSE:LLY) shares ticked up this morning on fourth-quarter results that beat the consensus forecast. The Indianapolis-based company posted profits of $2.1 billion or $2.32 per share, on sales of $7.4 billion for the three months ended Dec. 31, 2020, for a 41.5% bottom-line gain on sales growth of 21.7%. Adjusted to exclude one-time items,…

Included in President Joe Biden’s sprawling strategy document for dealing with the COVID-19 pandemic are an array of plans intended to ramp up vaccination efforts. Also in the plan are proposals for accelerating the development of therapies such as antiviral compounds effective against SARS-CoV-2 and other coronaviruses with pandemic potential. The “full-scale, wartime” plans have considerable relevance…

The perpetrators of a cyberattack against the European Medicines Agency found and later released data regarding the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).  But the cybercriminals altered the data in a manner that could undermine trust in vaccines, according to a statement from the European Medicines Agency (EMA). The disclosed documents included internal emails from late 2020 that contained…

AstraZeneca (LON:AZN) inadvertently discovered halving the first dose of its COVID-19 vaccine could boost its efficacy. Researchers at the National Institutes of Health (NIH) and Moderna (NSDQ:MRNA) are examining vaccine data to determine whether they can halve the 100-microgram dose to vaccinate twice as many people. Some data from Moderna’s clinical trial support that possibility,…

The U.K. has delayed the second dose of COVID-19 vaccines to maximize the number of people who can receive the first vaccine dose.   The move to delay administering the second dose by up to 12 weeks has prompted criticism from some physicians. The British Medical Association criticized the delay as “grossly unfair.” Dr. Anthony Fauci recently said he…

India is allowing reserved emergency use of the AstraZeneca (LON:AZN) COVID-19 vaccine and another from the domestic firm Bharat Biotech.  The country is producing both vaccines internally. Serum Institute of India has a contract to manufacture the AstraZeneca vaccine and has stockpiled between 40 and 50 million doses.  Covaxin, the vaccine from Bharat Biotech, was…