Guyana confident WHO will approve SPUTNIK V

GUYANA IS CONFIDENT THE WORLD HEALTH ORGANISATION (WHO) WILL
APPROVE THE RUSSIAN-MANUFACTURED SPUTNIK V VACCINE the country’s
Health Minister, Dr Frank Anthony, divulged during interactions with the media Wednesday.
Dr. Anthony believes that the WHO backing is nearer since its Scientific Committee has been
reviewing the COVID-19 vaccine   developed by Russia’s Gamaleya National Centre of
Epidemiology and Microbiology.
More than 70 countries worldwide currently use the SPUTNIK V in the fight against the
contagious and deadly virus which has so far killed more than 3.8 million globally and over 450
in Guyana since the country’s first case in March 2020.
“We are using the Sputnik V vaccine and at some point, we know that the WHO will approve it
as well because it has been pending at the scientific committee for the WHO waiting for that
approval. So, I know that they (WHO) will approve it and I guess when they approve it then
countries will accept this vaccine and probably would shorten the quarantine period. Right now,
there are 74 countries using the Sputnik V vaccine,” Anthony reasoned during Wednesday’s
virtual press conference.
Since April of this year, the European Medicines Agency (EMA) human medicines committee
began a rolling review of Sputnik V (Gam-COVID-Vac), “based on results from laboratory
studies and clinical studies in adults,” it said on its website.
EMA said, “these studies indicate that Sputnik V triggers the production of antibodies and
immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-
19.”
Sputnik V prepares the body “to defend itself against infection with the SARS-CoV-2 virus. This
virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause
COVID-19,” explained the EMA.

EMA said the Sputnik V comprises two viruses of the adenovirus family – Ad26 and Ad5 –
which “have been modified to contain the gene for making the SARS-CoV-2 spike protein; they
cannot reproduce in the body and do not cause disease.”
“The two adenoviruses are given separately: Ad26 is used in the first dose and Ad5 is used in
the second to boost the vaccine’s effect,” the medical website explains.

Guyana uses multiple vaccines in the covid fight including AstraZeneca and Sinopharm, both
now WHO-approved. Minister Anthony said that the latter was still awaiting the global body’s
okay when Guyana began utilising it.
Sinopharm was eventually approved about one month ago.
What is a rolling review?

 A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising
medicine during a public health emergency.
 Normally, all data on a medicine or vaccine’s effectiveness, safety and quality and all required
documents must be ready at the start of the evaluation in a formal application for marketing
authorisation.
 In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they
become available from ongoing studies. Once the CHMP decides that sufficient data are available,
the company can submit a formal application. By reviewing the data as they become available,
the CHMP can come to an opinion on the medicine’s authorisation sooner.
o During the rolling review, and throughout the pandemic, EMA and its scientific committees are
supported by the COVID-19 EMA pandemic task force (COVID-ETF).
o This group brings together experts from across the European medicines regulatory network to
advise on the development, authorisation and safety monitoring of medicines and vaccines for
COVID-19 and facilitate quick and coordinated regulatory action.

Guyanese are anxious to receive their booster jab of SPUTNIK V before the 12-weeks expire
“Most persons are still within the 12 weeks. We remain confident that the second dose of the
vaccine will arrive within that time,” the health Minister said.
“In the meantime, I just want to encourage persons to come out and get their second doses of
AstraZeneca and Sinopharm which are available. Similarly, with Sinopharm vaccine, there are
persons who received their first dose and didn’t return for their second dose. We just want to
encourage them because if you get one shot, it’s not going to be adequate. Unless you getting the
JJ (Johnson & Johnson) vaccine which is one dose. All other vaccines are two doses as you got
to get your first and then you have to come back,” Dr Anthony pleaded.
Meanwhile, it is still uncertain if there are repercussions getting the second jab after the
mandatory 12-week stipulation expires.
“That would be challenging because for both AstraZeneca and Sputnik V, the maximum
that they are talking about is 12 weeks. After you get your first dose, within the first 21
days your immune system starts reacting and it stabilises by the 12 th week or so. After that
there is still some debate about how long it would last,” Dr Anthony explained.