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In the latest edition of our Weekly COVID19 R&D Tracker,
which has tracked progress and expected timelines of vaccines and
treatments for COVID19 since late April 2020, we take stock of
several key developments as the world battles new strains of the
virus while rolling out massive vaccination campaigns. Governments
are considering vaccinating twice as many people by using a single
dose regimen - will this backfire and actually disrupt the
campaigns?
Our baseline assumption remains unchanged: we expect that we
will likely have fully approved, effective vaccines with access to
large populations across several countries in mid-2021, enabling
the safe reopening of those economies. Until that time we are
likely to see - and have already seen - conditional/emergency
approvals of experimental vaccines in subset populations, and
vaccination campaigns have started in several critical markets.
While there have been criticisms of the perceived slow uptake of
vaccines in several countries, ultimately the distribution seen so
far is in-line with our expectations due to the high level of
logistical barriers and unrealistic target expectations. We should
see an impact on mortality from the vaccination campaigns in the US
and Europe in the Spring, but there will continue to be significant
outbreaks of the disease as the vaccination rates are unlikely to
be enough. The US will be slightly behind because of its larger
population of risk patients other than the elderly.
While regulatory approvals are coming in and more mature
clinical data are being released, there are several factors that we
currently do not know, or have limited information on, as the
vaccine campaigns roll out globally. This includes duration of
protection, efficacy against transmission, and efficacy in
children, as well as several other key clinical signpoints that
will have an important impact on the likely success of the
vaccination roll-out.
Meanwhile, a new strain of COVID-19 has emerged in the UK since
December 2020, and studies from Imperial College and London
Tropical School of Medicine have indicated that it is 50-70% more
infectious. There are weaknesses in the data here, and it is
important to consider here that hospitalization and mortality rates
so far are similar - fundamentally, the strain is very similar to
the hundreds of other mutations that we have seen so far. However,
increased rates of COVID-19, including the UK strain, have led to
increasingly urgent calls to alter the dosing regimens of vaccines
in order to maximise the available doses instead of ensuring that a
second dose is administered as per the label. This is playing with
fire and can lead build-up of confusion and mixed signals in the
vaccination campaigns, particularly for vaccines that had clearly
run clinical trial protocols such as the Pfizer/BioNTech
vaccine.
The UK's MHRA, which provided controversial, early approvals for
vaccines despite limited capacity and experience, has set the tone
here. For the AstraZeneca vaccine, the approval is for use in
people aged 18 or older and is administered in two full doses given
4-12 weeks apart. And countries such as Argentina, Dominican
Republic, El Salvador, Mexico, and Morocco have effectively
repurposed the UK approval their their own markets (and Argentina
is using the same 4-12 week dosing regimen as the UK). For the
Pfizer/BioNTech vaccine, administration can be 3-12 weeks apart in
the UK, rather than within three-week schedule in the clinical
trial protocol, despite no supporting data for this from the
clinical development programme.
Elsewhere around the world, the Russian Ministry of Health has
approved an amendment to the Phase III trial format for the
Gamaleya Institute's adenoviral-based COVID-19 vaccine Sputnik V to
terminate the placebo arm and allow further participants to receive
the vaccine only. This decision was made following the recent
establishment of protective efficacy of 91.4% for this vaccine from
the Phase III data. No new volunteers will be recruited for the
placebo group, although there are no plans as yet for unblinding
the trial. Monitoring of the unblinded trial will continue in full
accordance with the published protocol, including the existing
placebo group, for at least six months to obtain further details of
preventive efficacy and safety profile for the vaccine over a
longer period. Following its interim approvals in Russia and
Belarus, Sputnik V has also been approved in Argentina. In
addition, the Russian interim approval for this vaccine (in place
since last August) has now been expanded to include people aged
over 60, following an evaluation of separate trial data for this
age group.
Chinese firm Sinopharm has announced interim results from Phase
III clinical trials of its inactivated whole-virion COVID-19
vaccine BBIBP-CorV (BIBP), which reportedly demonstrated a 79.34%
efficacy rate. On the basis of these results, China's NMPA granted
conditional approval for this vaccine on 31 December. China becomes
the third country to release the vaccine for use in the general
population, following Bahrain and the UAE. The most recently
reported efficacy rate is lower than the 86% efficacy rate reported
by regulatory authorities in the UAE earlier this month for the
same vaccine, and reasons for this discrepancy (and numbers of
supporting infected cases) have not yet been disclosed. However,
Sinopharm indicated in a statement that the discrepancy could be
explained by factors including "differences in diagnostic criteria"
between countries, and plans to publish data in international
research journals. The vaccine has also received an EUA in
Egypt.
The Indian authorities have issued an EUA for Bharat Biotech's
Covaxin (BBV152B) after a Phase III efficacy trial was initiated in
India in 25,800 participants; so far, about 22,500 volunteers have
received the vaccine and regulators state that data available to
date demonstrate that it is safe. This is first indigenously
developed COVID-19 vaccine to be rolled out in India and occurred
at the same time as the EUA for the Serum Institute of India
(SII)'s local version of the AstraZeneca vaccine, Covishield, based
on international and local trials of the original and locally
produced versions.
Posted 11 January 2021 by Gustav Ando, Vice President, Industry Services & Life Sciences, IHS Markit and
Janet Beal, Senior Research Analyst, Life Sciences, IHS Markit