COVID-19

The third vaccine to win emergency use authorization in the U.S. could reappear after a 10-day pause, according to Dr. Anthony Fauci, the nation’s top disease expert. FDA and CDC had recommended temporarily suspending the use of the Johnson & Johnson (NYSE:JNJ) vaccine after six women developed serious blood clots within weeks of vaccination. Fauci…

The European Union has decided to exercise an option to purchase additional doses of the Comirnaty COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).  The two companies will deliver 600 million doses of the vaccine to the EU in 2021.  The Continent’s mass-vaccination efforts have sputtered for much of early 2021, given supply constraints related…

Eli Lilly (NYSE:LLY) announced that it had amended purchase agreements with the U.S. government to prioritize using two monoclonal antibodies — bamlanivimab and etesevimab — in tandem. In March, the U.S. government announced that it would stop using bamlanivimab alone, given its reduced efficacy against some SARS-CoV-2 variants. But pairing anti-SARS-CoV-2 monoclonal antibodies together can offer more…

The recent spectacle surrounding Vaxzevria, the AstraZeneca (LON:AZN) COVID-19 vaccine, could exacerbate vaccine hesitancy, which is significant in many parts of the world. In the U.S., the independent data and safety monitoring board overseeing the Phase 3 trial contacted government authorities with concerns that the summary data were misleading. More recently, the European Medicines Agency (EMA)…

Johnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility. The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines. New Brunswick, N.J.–based J&J’s single-dose vaccine was authorized…

A former FDA inspector accused the agency of downplaying safety problems at a Merck plant tapped to manufacture Johnson & Johnson’s COVID-19 vaccine.  The whistleblower alleged that a 2018 inspection uncovered evidence that employees in the facility in Durham, N.C. engaged in a host of unsanitary practices. A letter to President Biden from the U.S.…

Employees at an Emergent BioSolutions (NYSE:EBS) facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded. A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did not meet quality…

Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature. Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the…

After the number of COVID-19 infections began to incline steeply, India has decided to retain most of the vaccines produced in the country. The country has also announced plans to lower the eligibility requirements to all citizens 45 or older starting April 1. The Serum Institute of India is one of the world’s biggest vaccine…

BioNTech has won approval from the European Medicines Agency (EMA) to manufacture its COVID-19 vaccine Marburg, Germany–based facility. BioNTech will produce mRNA at the site, an instrumental component of the Comirnaty (BNT162b2) vaccine it jointly developed with Pfizer. The manufacturing for the vaccine process requires approximately 50,000 steps, which spans mRNA synthesis and manufacture of…