4 March 2021

• The EMA announces that it is conducting a rolling review of data on the Sputnik V coronavirus vaccine. Source
• In Turkey, Professor Serhat Unal, who headed the 10,030-person  phase III clinical trial of Sinovac’s coronavirus vaccine, announced that efficacy dropped from an interim result of 91.25 percent among 1,322 people (which was reported in December), to 83.5 percent, with 32 of 41 infections among people who got placebo – although the vaccine was 100% effective at  preventing severe illness and hospitalization. Source
• Novavax reports 51 percent overall efficacy of  its coronavirus vaccine in a 4,387-person phase IIb clinical trial in South Africa, where over 90 percent of COVID-019 cases during the study were caused by the B.1.351 variant. The vaccine was 60.1 percent effective for HIV-negative study participants, and 49.4 percent effective for HIV-positive study participants.  The researchers noted that a prior coronavirus infection did not protect people from the B.1.351 variant. Source
• Italy blocks over 250,000 doses of the AstraZeneca coronavirus vaccines from being flown to Australia, invoking a new EU regulation that  stops vaccines produced within the bloc  from being sent abroad if the manufacturer has not yet met its supply obligations to member countries. Source
• The UK Medicines and Healthcare Products Regulatory Agency announced that it will fast-track the process  for coronavirus vaccines that are adapted to new variants, basing approval on evidence of immune responses rather than full clinical trials; vaccines producers need to demonstrate the safety of their products and can draw from  clinical trials of the original vaccine as well as from vaccine roll-out programs. Source
• Novartis announced that it will help to manufacture the bulk drug substance for CureVac’s mRNA coronavirus vaccine; this will enable production of as many as 50 million doses by the end of 2021 and 200 million doses by the end of 2022. Source
• During a meeting of the World Bank, Adar Poonawalla, head of India’s Serum Institute, warned that a US law, the Defense Production Act – which was invoked to help Pfizer scale up coronavirus production – is blocking exports of raw materials for vaccine production (such as vials, glass, plastic and stoppers), which could cause serious delays.  WHO will hold a meeting with the International Federation of Pharmaceutical Manufacturers and Associations and the Developing Countries Vaccine Manufacturers Network to discuss global coordination of supplies. Source
Bloomberg reports that Israel’s Prime Minister, Benjamin Netanyahu, paid Pfizer $30 per dose for its coronavirus vaccine (about 50 percent more than the US price) and offered to share national data with the company, which began shipping millions of doses to Israel – so much that it has not used 100,000 doses of the Moderna vaccine. At the same time, Pfizer delayed and/or sent smaller shipments  of its vaccine to the EU (where they discussed an initial price of €54 per dose, later dropped to €15 to €30, depending on volume), Bahrain, Canada (which wound up ordering vaccines from COVAX to make up for the shortage), Mexico, Oman and Saudi Arabia (both of which are paying $30 per vaccine).

Pfizer- which invested $2 billion in the vaccine- expects initial profit of 20 percent, and $15 billion in revenue this year, plans to freeze-dry the vaccine to make it easier to ship and store – and post-pandemic vaccine price hikes, according to its Chief Financial Officer Frank D’Amelio, who said “We’re in a pandemic pricing environment,” he said. “Obviously we’re going to get more on price.” Source
• The NIH halts two sub- studies of  potential COVID-19 therapies – VIR-7831, a monoclonal antibody, and a combination monoclonal antibody therapy containing BRII-196 and BRII-198, both for futility. Source
• A 476-person clinical trial of ivermectin in people with mild COVID-19 did not find that it shortened symptoms. Source

Return to the timeline