. (Photo: VNA)the Ministry of Health on September 19 issued a press statement on its
conclusions of a meeting one day earlier during which it looked into the mid-term phase 3 trial’s
results of homegrown vaccine Nano Covax.
The
data available for review is from the developers – Nanogen Pharmaceutical
Biotechnology JSC in Ho Chi Minh City with the support in administration and
medical monitoring from the Military Medical University in Hanoi – up until
September 2 this year, as the final phase of clinical trials is ongoing for the
recombinant DNA vaccine.
Regarding
the vaccine safety, Nano Covax is deemed to be safe in the short term
based on reports of phase 3 trials (during the monitoring of the volunteers’
health seven days after administration of the first dose for 11,430 volunteers,
seven days after the administration of second doses for 5,785 volunteers).
Regarding
immunogenicity, Nano Covax is deemed to be able to elicit immune responses,
based on ongoing phase 3 results – anti-SARS-CoV-2 IgG test results on 924
samples 42 days after first jab; results of neutralising antibodies tests on
761 samples 42 days after first jab; plaque-reduction neutralisation test 42
days after the first jab on 107 samples with the first detected strain of
coronavirus, 41 samples with Delta variant, 39 samples with Alpha variant.
The
council’s statement stressed that to date they haven’t had the data to
“directly” evaluate the protective efficacy, or the ability of a vaccine
to prevent infection or symptomatic infections (based on of the number of
people infected with COVID-19 after getting the shots), and said more study is
needed for assessment of this “most important criteria to determine the
vaccine’s quality.”
The
currently available estimation of Nano Covax’s protective efficacy extrapolated
from its immunogenicity, or the level of antibodies in the vaccinated, however,
has “enough scientific grounds” for the council to send the vaccine documents
to the Advisory Council for the Registration of Circulation of Drugs and
Medicinal Ingredients for reviews.
Regarding
the proposal to grant Nano Covax conditional approval for emergency use,
the ethics committee said they reached ‘consensus’ in the use of mid-term
phase 3 trials for the drugs advisory body to deliberate.
But
it asked the vaccine candidate’s developers to supplement their reports as per
the conclusions of the meeting and continue with the trials of the vaccine
based on the approved outline to complete trials in March 2022, and give timely
updates to the relevant committees and health authorities.
Experts
from the Advisory Council for the Registration of Circulation of Drugs and
Medicinal Ingredients, who will take up the case and make decisions on whether
to give the emergency approval for the vaccine to be used in Vietnam, were also
present at the meeting, the press statement reads.
Currently,
13,000 volunteers in phase 3 trials of Nano Covax – which started on July
and is set to wrap up by 2022 February – have been given the second shots
of the vaccine with dosage set at 25mcg.
Under
the latest guidelines from the health ministry, domestically developed COVID-19
vaccines could be authorised for emergency use if they prove to be safe and
effective in mid-term phase 3 findings, with further monitoring required even
after obtaining such approval./.
Source: VietnamPlus
