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
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.
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.