Local pharmaceutical company Lloyd Laboratories Inc. said Thursday it plans to release a new COVID-19 vaccine that can complement current vaccines in the market once it obtains an emergency use authorization approval from the Food and Drugs Administration by February.
LLI executives said in a virtual interview technology partner Livzon Mabpharm Inc. of China was wrapping up the third and final clinical study for the vaccine and that they would submit their application for EUA and certificate of product registration next month.
“We are not going into the basic vaccine development. We are interested in the fill and finish locally,” said LLI vice president for technical and research Chandra Shekhara Reddy Nagareddy.
LLI has a facility capable of filling prefilled syringes. Civil works for an extension facility for the fill and finish operations started in 2021 and were still in the works, according to LLI director for business Christopher Bamba.
The first and second clinical studies were carried in China while the third phase ws ongoing in the Philippines, Indonesia and Russia. More than half of 21,500 subjects came from the Philippines.
The pharmaceutical company said it would lock its database next week to proceed with the interim analysis needed for EUA application.
Bamba said its Chinese partner was willing to do a full technology transfer where it would provide the product for final repacking in the Philippines.
“For now, we refer to the vaccine as VO-1 since it does not have an official name yet. Our technology partner has the capability to manufacture the vaccine in billions of doses in a short period of time,” he said.
Lloyd Laboratories also has a pending application for certificate of product registration with the FDA for the manufacture of COVID oral therapy Molnupiravir.
The company’s facility in Bulacan has the capacity to produce 1 million capsules of Molnupiravir in a single batch or over the course of 3 to 4 days.
LLI’s entry into the production of Molnupiravir will help reduce the price of the drug by 30 to 50 percent. At present, COVID drugs are for institutional deployment yo hospitals, clinics and quarantine facilities.
Bamba said the company is poised to become a major supplier and manufacturer of COVID-related medical products.
It is currently manufacturing Ivermectin for human use, the first and only Filipino pharmaceutical company awarded the EUA to produce Ivermectin for humans.