Healthcare Roundup – Sinovac’s COVID-19 vaccine offered by Chinese city for emergency use, CytoDyn to discuss DSMC’s review of interim analysis in COVID-19
Sinovac’s COVID-19 vaccine offered by Chinese city for emergency use costs $60 – Reuters
Jiaxin city in China is offering Sinovac Biotech’s (NASDAQ:SVA) investigational COVID-19 vaccine to essential workers and other high-risk groups as part of a national program, for ~$60.
The eastern city of Jiaxin’s center for disease control and prevention said that two doses of the vaccine candidate, called CoronaVac, will cost 200 yuan ($29.75) per dose, though it was not clear if the pricing includes subsidies.
Bio Farma in Indonesia which reached a deal for at least 40M doses from Sinovac, said the vaccine will cost around 200k rupiah ($13.60) per dose when it becomes available.
China National Pharmaceutical Group (Sinopharm) said in August that a vaccine candidate developed by a unit may cost no more than 1,000 yuan ($148.80) for two shots. An official at China’s National Health Commission has said, however, the price will be lower.
CytoDyn to discuss DSMC’s review of interim analysis in COVID-19 on October 20
CytoDyn (OTCQB:CYDY) will host an investment community webcast on Tuesday, October 20.
Management will discuss the recommendations of the Data Safety Monitoring Committee (DSMC) following their review of the interim analysis of the first 195 patients enrolled in the Company’s Phase 2b/3 clinical trial for patients with severe-to-critical COVID-19 indications, including a potential regulatory path forward.
Pfizer may apply for emergency use of COVID-19 vaccine by late November: CEO Albert Bourla
In an open letter from Pfizer (NYSE:PFE) Chairman and CEO Albert Bourla, the company provide greater clarity around the development timelines for its and partner BioNTech’s (NASDAQ:BNTX) COVID-19 vaccine.
PFE said it could be ready to apply for emergency-use authorization (EUA) of its COVID-19 vaccine by late November, assuming it receives positive efficacy and safety data from late-stage human trials.
To grant EUA, FDA requires companies to provide two months of safety data on half of the trial participants.
All the data would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.
The drug giant also said that it will continue running the trial through its final analysis point even if it is declared effective at an earlier stage.
PFE and BNTX are committed to supplying over 450M doses of COVID-19 this year and next year, contingent on the efficacy.
The U.S. government placed an initial order of 100M doses, with the option to purchase 500M additional doses.
The EU ordered 200M doses with an option for another 100M.
The government of Japan ordered 120M doses, and Britain ordered 30M.
All orders are subject to regulatory approval, and only the price of the U.S. deal – $1.95B – has been disclosed so far.
European advisory group backs Gilead’s KTE-X19 in white blood cell cancer
The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Gilead Sciences (NASDAQ:GILD) unit Kite Pharma’s CAR T therapy KTE-X19 for the treatment of adults with relapsed/refractory mantle cell lymphoma, a rare and aggressive type of non-Hodgkin lymphoma.
The CHMP opinion recommends conditional authorization, an early access pathway for medicines, but for which comprehensive data are not available.
A final decision from the European Commission usually takes ~60 days.
Kite Pharma is expected to become the first company with multiple approved CAR T therapies in Europe.
Lilly/Incyte’s baricitinib shows additional benefit in hospitalized COVID-19 patients
Eli Lilly (LLY -0.5%) and its collaborating partner Incyte (INCY +0.1%) have announced additional efficacy and safety data from Adaptive COVID-19 treatment trial (ACTT-2), demonstrating baricitinib in combination with remdesivir reduced recovery time and improved clinical outcomes for patients with COVID-19 infection, compared with remdesivir alone.
Most significant benefits were observed in patients requiring supplemental oxygen and those who required high-flow oxygen/non-invasive ventilation.
As previously reported, ACTT-2 achieved the primary endpoint, demonstrating that the overall patient population treated with baricitinib+remdesivir combo improved their median time to recovery from 8 to 7 days in comparison to remdesivir, a 12.5% improvement.
New data showed numerical decrease in death (35%) through Day 29 was observed in patients treated with baricitinib plus remdesivir compared to remdesivir alone (5.1% vs. 7.8%), respectively.
No new safety signals were observed for baricitinib-treated patients in this study.
Last week’s announced new data showed that the odds of improvement in clinical status at day 15 were 30% greater in the baricitinib arm.