National Institutes of Health official Dr. Anthony Fauci (C) speaks about the coronavirus during a press briefing at the White House in Washington, D.C. Health and Human Services Secretary Alexander Azar (L) announced that the United States is declaring the virus a public health emergency and issued a federal quarantine order of 14 days for 195 Americans. Photo by Leigh Vogel/UPI | License Photo
June 2 (UPI) -- The World Health Organization has granted emergency use authorization of the Chinese manufactured Sinovac COVID-19 vaccine for those 18 years of age and older.
The WHO announced its validation of the two-shot regimen by Beijing-based pharmaceutical Sinovac in a statement Tuesday, informing countries, procuring agencies and communities that the drug is safe and meets international standards.
The WHO's Strategic Advisory Group of Experts on Immunization said following a review of the vaccine that it has recommended it for use in adults 18 years and older, with the two doses to be administered between two and four weeks apart.
"The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe," said Dr. Mariangela Simao, WHO's assistant-director general for access to health products.
The emergency use listing also makes the drug available to the WHO-led COVAX facility, which seeks equitable access to vaccines, for supply and international procurement while signaling other countries to consider giving it national approval for use.
The Sinovac drug has shown an efficacy rate of 51% in preventing symptomatic COVID-19 illness but a 100% efficacy at preventing severe illness and hospitalization, according to clinical trial results.
However, few adults over the age of 60 years old were enrolled in trials making it difficult to estimate the efficacy for this demographic, but the WHO said it is not enforcing a upper age limit on its use as data collected from countries that have administered the drug suggest it is "likely to have a protective effect in older persons."
"There is no reason to believe that the vaccine has a different safety profile in older and younger populations," the U.N. health body said. "WHO recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to verify the expected impact and contribute to making the recommendation more robust for all countries."
The WHO also said that since it is an inactive vaccine it is easy to store, making it suitable for low-resource setting.
During a press conference Tuesday, WHO Director-General Tedros Adhanom Ghebreyesus told reporters it was the eighth vaccine to get emergency use listing by the WHO.
"It's now crucial to get these life-saving tools to the people who need them quickly," he said.
The Sinovac vaccine becomes the second Chinese made drug and eighth total recommended for emergency use by the WHO since Jan. 8 when it signed off on Pfizer.