Revisions to Brazil's drug price framework are coming - what's included and what's missing? Our analysts provide th… https://t.co/8s17gnKCXf
COVID19 Research and Development Tracker: Vaccine rollouts, dosing controversies and new strains
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.
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Major changes to Czech P&R regulations for orphan and high-cost drugs set to expand access. What role will IRP play… https://t.co/bQcVCG5jut