Sinovac’s shot — which was just effective enough to meet regulatory standards — is now the first Chinese Covid-19 vaccine to be considered by the European Medicines Agency.
The EMA’s human medicines committee (CHMP) said on Tuesday that it’s kicking off a rolling review of the inactivated vaccine, dubbed CoronaVac in some regions, in an attempt to speed up the regulatory process. The agency will look at data as they become available to determine whether the benefits of the jab outweigh the risks.
Hungary became the first country in the EU to allow emergency use of the shot back in January, following a government decree that any vaccine given to at least a million people worldwide can now be approved for use without passing through the country’s medicines regulator, according to the AP.
In February, Sinovac announced the candidate was just 50.65% effective against all Covid-19 cases in Phase III studies conducted in Brazil and Turkey in healthcare workers. The biotech said efficacy was 83.70% for cases requiring medical treatment, and 100.00% for hospitalized, severe, and fatal cases.
It should be noted that in an analysis of 29 cases among participants who belonged to the general public in Turkey, Sinovac says its candidate was 91.25% effective at Covid-19 prevention 14 days after the two-dose vaccination.
“EMA will assess the compliance of COVID-19 Vaccine (Vero Cell) Inactivated with the usual EU standards for effectiveness, safety and quality,” the EMA said in a statement.
CoronaVac was one of the vaccines authorized for emergency use by the Chinese government in July, according to a Reuters report citing an unnamed official. The candidates were administered to some medical professionals and border officers, a Chinese official said in an interview with state media. — Nicole DeFeudis
After 100% efficacy trial, teenagers could be eligible for Pfizer’s vaccine next week
Teenagers between the ages of 12 and 15 could be eligible to receive the Pfizer-BioNTech Covid-19 vaccine as early as next week, The New York Times has reported. The company released its trial results toward the end of March, and found that no symptomatic infections occurred in patients within this age group.
The announcement is a step toward an attempt at reaching herd immunity. In February, NIAID director Anthony Fauci said that children as young as first graders could be eligible for the vaccine by the time school starts in September. That eligibility is likely to ease the minds of educators across the country, who have grappled with the delicate balance of providing an adequate education for students and providing a safe work environment for its staff all year.
Pfizer’s trial consisted of 2,260 adolescents, and there were 18 cases of Covid-19 that appeared in the placebo group, compared to none in the vaccinated group, the company said.
So far, there have been about 65 million doses of Covid-19 vaccines that have been delivered but not administered, the Times said. A little less than half — 31 million — of those are Pfizer-BioNTech’s vaccine, which requires 2 doses per individual to be fully effective. — Josh Sullivan
Lilly donates 400,000 baricitinib tablets to India
Eli Lilly said Tuesday that it’s initially donating 400,000 baricitinib tablets to the Indian government for eligible hospitalized Covid-19 patients and the company said it will work urgently to increase the quantity of donated product multifold over the coming weeks.
The RA drug baricitinib when combined with Gilead’s remdesivir has an emergency use authorization in the US to treat those hospitalized with Covid-19. Lilly said that on Monday it received permission for restricted emergency use for baricitinib (2 mg and 4 mg) in combination with remdesivir, for treatment of suspected or laboratory confirmed Covid-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. — Zachary Brennan
A lawsuit in Russia challenges government who tasked domestic company to make Gilead’s remdesivir
The filing accuses The Pharmasyntez Company of using Gilead’s process for manufacturing remdesivir without the consent of the patent holder.
Late in 2020, the government issued a compulsory license to Pharmasyntez, who then approached Gilead about potentially manufacturing a version of the medicine, STAT reported. The company had plans to sell the drug at half the cost for national security’s sake.
Court session for the suit is scheduled to begin on May 27.
The decision comes with a debate over global access to Covid-19 treatments and vaccines for countries in need. As the US has secured 1 billion doses of the vaccine, some ethicists have said that doses should be shared with other countries sooner rather than later. Bill Gates recently received backlash for saying in an interview that the US should keep vaccine patents exclusive, citing security and cost issues. — Josh Sullivan
Novavax will expand Phase III trial to teenagers
Just hours before it was reported that Pfizer/BioNTech’s Covid-19 vaccine will be available for adolescents at the beginning of next week, Novavax has announced that it has initiated the pediatric expansion of its Phase III clinical trial for its own vaccine.
The trial will evaluate 3,000 adolescents between the ages of 12 and 17 at 75 sites throughout the US, the company said in a statement. Participants will either receive the vaccine or the placebo in 2 doses 21 days apart from each other, and they will be monitored for safety up to 2 years after the final dose.
The company’s jab has still not yet been approved anywhere in the world.
Novavax announced Monday that it will ship 200 million doses to the EU as a part of a draft supply deal that was signed in December, despite the fact that the maker has been plagued with production problems. In a conversation with Endpoints’ Jason Mast, Novavax said it has worked to overcome supply-chain challenges, including for materials as diverse as Chilean tree bark and bioreactor bags. — Josh Sullivan
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Gilead Stock – EMA begins rolling review of first Chinese vaccine; After 100% efficacy trial, teenagers could be eligible for Pfizer’s vaccine next week – Endpoints News
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