MPs Recommend Patenting, Clinical Studies on Three COVID-19 Potential Vaccines

Xavier Kyooma, the Committee Chairperson says that although a candidate vaccine was identified, there is no indication that it has been patented, which casts doubt on its identification.
The Oxford/AstraZeneca COVID-19 vaccine
A committee of Parliament that was established to investigate the development of a COVID-19 vaccine has recommended a speedy process of patenting and clinical studies.

The committee was set up in November 2021 to investigate alleged irregularities regarding the utilization of COVID-19 vaccine development funds by the Presidential Scientific Initiative on Epidemics (PRESIDE). The initiative, supervised by Dr Monica Musenero, who is currently the Minister of Science, Technology, and Innovation, is a brainchild of President Yoweri Museveni.

PRESIDE selected four projects for vaccine development and the committee learnt that three of these have progressed, while one stalled. Those that have progressed are the COVID-19 Sub-unit Vaccine project, the Novel Adenovector COVID-19 Vaccine and the Inactivated COVID-19 Vaccine development project. The Self-Amplifying RNA Vaccine project stalled.

All vaccines go through three stages of development including the exploratory stage, pre-clinical stage and clinical stage. The exploratory stage involves carrying out laboratory research to isolate candidate vaccines that could trigger immune responses, the pre-clinical stage involves the use of laboratory and animal studies to identify safety concerns before testing vaccines in humans and to also identify the safest dose for administration, while the clinical stage involves testing vaccines in humans.

According to the Select Committee report, a sub-unit vaccine that only uses specific parts of a virus to trigger an immune response had been developed and completed in pre-clinical studies in ordinary mice, with data analysis being in the final stages. However, Xavier Kyooma, the Committee Chairperson says that although a candidate vaccine was identified, there is no indication that it has been patented, which casts doubt on its identification.

Kyooma argues that although Dr Musenero indicated that preclinical trials in ordinary mice had been completed, and in the final stages of data analysis, her conclusion that the vaccine was safe and had elicited a strong immune response was premature since data analysis was still ongoing. The committee recommends that candidate vaccines should be expeditiously patented and preclinical studies should be concluded so as to ascertain their efficacy.

In regard to the second candidate vaccine - the Novel Adenovector, MPs recommend that the Auditor General assesses whether it has indeed been isolated. While appearing before the committee, Minister Musenero indicated that this vaccine had been developed, entered the patenting pipeline and is undergoing preclinical animal studies in mice.

Kyooma says that if this is ascertained, further funding support should be given to Uganda Virus Research Institute - UVRI to enable progress to preclinical and clinical trials. This vaccine is based on the human adenovirus 5 (Ad5), the same platform which was used for developing AstraZeneca and Johnson & Johnson vaccines. It involves modifying viral vectors that generate immune responses.

The third vaccine project- the inactivated COVID-19 vaccine involves killing disease-carrying viruses using chemicals, heat and radiation and the resultant vaccine is used to trigger an immune response.

“The Committee was informed that as of March 2022, samples for the vaccine had been collected, isolated and expanded to prepare bulk stocks. The stocks were then inactivated and were in pre-clinical trials. Further, the scientists' presentations reported that preclinical studies were on course, and were expected to continue up to the end of 2022,” Kyooma says.

The MPs now want expeditious preclinical and clinical studies for this vaccine, upon which, approvals from the National Drug Authority -NDA should be acquired and then pre-qualification exercise fast-tracked with the World Health Organisation-WHO.

According to WHO, once a vaccine has reached the pre-approval stage following clinical trials, it is assessed by the relevant regulatory body for compliance with quality, safety and efficacy criteria.

Following regulatory approval, manufacturers can then submit a vaccine to the WHO for prequalification; an assessment process that ensures quality, safety and efficacy which helps the United Nations -UN and other international procurement organizations determine the suitability of a vaccine.

Once a vaccine is authorized, manufacturing begins to scale up. According to the World Health Organization (WHO), approximately 7 per cent of vaccines proceed to clinical stages and of these, only 20 per cent have a chance of success. The WHO estimates that the whole process, from preclinical trial to manufacture, may take up to a decade to complete.