Aurobindo Pharma on May 31 said the drug maker and its partner Vaxxinity had approached DCGI last week seeking permission to conduct Phase-2/3 clinical trials of its COVID-19 vaccine UB-612.
N Govindarajan, Managing Director of Aurobindo Pharma, at the company's earnings call on Monday said that the drug maker expects the approval of UB-612 in December or January next year if everything goes according to their plan.
Aurobindo Pharma had entered into an exclusive agreement with US biotech company COVAXX in December 2020 to develop and manufacture UB-612 for India and UNICEF. COVAXX was renamed as Vaxxinity in April 2021. UB-612 is based on virus-like particle (VLP) or peptide based platform. Aurobindo Pharma has exclusive rights to develop and commercialize UB-612 in India and to UNICEF and non-exclusive rights in other select emerging markets
Aurobindo Pharma can supply up to 480 million doses of UB-612 for India and other countries
Change of plan
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Govindarajan said originally the collaborator (Vaxxinity) thought that they would do the trial in Brazil and have waited for 4-5 months to begin, but it did not work out because the variant was changing (mutating) and they didn't want to drag that, hence they decided to do the trial in India.
Aurobindo Pharma plan to initiate clinical trials of UB-612 didn't materialise, as the Subject Expert Committee (SEC) of CDSCO which reviewed Aurobindo's proposal in February recommended that the firm should submit the Phase II/III clinical trial protocol approved by the regulatory authority of Brazil. It also suggested some revisions to the protocol.
"We had a pre-submission discussion (with the SEC) to the extent we do not expect too many queries. Most of the queries are taken into consideration," Govindarajan said
"We expect the SEC approval to happen..., we would be starting the trial in India," Govindarajan added.
Meanwhile Vaccinity is in the process of seeking emergency use approval (EUA) from Taiwan in the second half of July. Based on Taiwanese regulatory approval, Vaccinity is planning to seek approval in other emerging markets.
Aurobindo Pharma said in anticipation of Taiwan approval - the company would begin production of 25 million doses, which can be expanded as the requirement goes up.
"They are already in discussion with us to start manufacturing in anticipation of that approval. The opportunity of contract manufacturing will start in near future," Govindarajan said.
Govindarajan said UB-612 can be produced in a general injectable plant or its bacterial vaccine facility that is built for the purpose of pneumococcal conjugate vaccine (PCV). Aurobindo is expecting approval of PCV next year.
In addition to UB-612, Aurobindo is also setting up a new facility to manufacture viral vector vaccines with an investment of Rs 250-Rs 275 crore . The company’s upcoming vaccine facility will have the capacity to manufacture 400 - 450 million doses of COVID-19 vaccines.
"Our viral vector vaccine facility - all equipment will be installed and all the qualification for equipment will be completed by June end. From July onwards our process validation would start. We can start our commercial batches after that," Govindarajan said.
Govindarajan said the company is exploring partnerships with other vaccine developers to produce COVID-19 vaccine at the upcoming manufacturing site.