China-made COVID vaccine up for clinical trials
REUTERS File Photo
MANILA, Philippines — The Food and Drug Administration (FDA) has allowed a Chinese drugmaker to hold clinical trials in the country for a vaccine that supposedly provides immunity for more than 20 months.
Beijing-based Yisheng Biopharma said in a statement that the phase 2 and phase 3 trials would be held at five health centers for its Pika jab which targets six COVID-19 variants, including Omicron BA.4 and Omicron BA. 5.
Based on the latest genome sequencing run of the Philippine Genome Center from July 15 to Sept. 3, the BA.5 remains the dominant strain circulating in the country, accounting for about 86 percent of the total samples sequenced.
The trials will be held at the research center of the University of the East Ramon Magsaysay Memorial Medical Center in Quezon City, Health Index Multispecialty Clinic in Bacoor City, Tropical Disease Foundation in Makati City, St. John Hospital in Naga City, and Norzel Medical and Diagnostic Clinic in Cebu City.
Wide range of strains
“Pika recombinant COVID-19 vaccine candidate achieved high levels of immunogenicity and broad neutralizing antibodies in clinical trials against a wide range of strains, including the most prevalent Omicron variant,” Yisheng Biopharma chair Yi Zhang was quoted in the statement as saying.
The drugmaker said the Pika vaccine can be used as booster shots for those who have received at least two doses of inactivated COVID-19 jabs.
Meanwhile, the FDA said in a Sept. 14 advisory that Paxlovid, the COVID-19 pill developed by drugmaker Pfizer, still remains under compassionate special permit (CSP) because its importer has yet to comply with supply chain regulations six months after it was given regulatory approval.
Paxlovid is a combination of antiviral medications nirmatrelvir and ritonavir, and is one of three COVID-19 medications with regulatory approval. The two others are molnupiravir and casirivimab/imdevimab under the brand name Ronapreve.
On March 10, Paxlovid was granted emergency use authorization (EUA), which is issued to unregistered drugs and vaccines in a public health emergency. A CSP, meanwhile, is a special permit granted to physicians and hospitals for the use of an unregistered drug.
Under the EUA, Paxlovid can be taken by adolescents and adults, or those at least 12 years old with a minimum weight of 40 kilograms, who have no severe symptoms and do not need to be hospitalized.
It required Pfizer to craft a comprehensive pharmacovigilance system for its COVID-19 drug and submit monthly adverse reactions and safety reports to the FDA.
