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December 3, 2020
Glaxo-Backed Vaccine Shows Strong Immune Response in Early Trial (5:23 p.m. HK)
A Covid-19 vaccine project supported by GlaxoSmithKline Plc is headed for advanced trials after showing a strong immune response in early studies. Sichuan Clover Biopharmaceuticals Inc. of China said its shot induced neutralizing antibodies and proved to be safe in a study of 150 adults and elderly volunteers. The vaccine uses adjuvants — agents that boost a vaccine’s response — from both Glaxo and Dynavax Technologies Corp. Reference
Sweden Aims to Get 2 Million Vaccines in First Quarter (5:16 p.m. HK)
Sweden expects to get enough Covid-19 vaccines to immunize a fifth of the population in the first quarter of 2021, Prime Minister Stefan Lofven said Friday.
The nation has secured vaccines from Pfizer Inc., Moderna Inc., AstraZeneca Plc, Janssen Pharmaceuticals Inc and CureVac NV through European Union agreements. Immunizations are scheduled to start on a smaller scale in January, with 4 million doses — enough for 2 million people – expected to be delivered by the end of March.
The vaccination program will give priority to residents and staff at care homes, as well as the elderly receiving assistance at home, Public Health Agency director-general Johan Carlson said at a news briefing. Reference
Bloomberg: Tracking the Coronavirus Vaccines That Will End the Pandemic
Bloomberg is tracking nine of the most promising vaccines around the globe, from national procurement deals to shots in patients’ arms. By our count, at least 7.85 billion doses have already been allotted.
It’s enough to cover half the world’s population (most vaccines use two doses), if the shots were distributed evenly. That, however, isn’t likely. Rich countries have hedged their bets with extensive supply deals, and ultra-cold storage requirements make some vaccines difficult to deliver to far-flung places. Reference
Israel in negotiations with Novavax to purchase COVID-19 vaccine
Israel is in negotiations with the Maryland-based biotech company Novavax to receive its vaccine candidate, Prime Minister Benjamin Netanyahu said Wednesday.
All of the new vaccines are based on the viral spike protein. However, whereas Moderna, Pfizer and AstraZeneca vaccine candidates are based on the gene of the spike protein, Novovax vaccine is a subunit vaccine that is based on the spike protein itself.
This is the same type of vaccine as the hepatitis B surface antigen vaccine that is given to babies at birth.News of the potentially new contract comes on the same day that the number of red and orange zones across Israel increased, as the Health Ministry shifted the criteria for labeling cities within the traffic light program on Wednesday. Reference
Novavax: Several Catalysts on the Horizon
Novavax, NVX-CoV2373 is currently in a Phase 3 trial in the U.K. and a phase 2b study in South Africa, both of which are now fully enrolled. While the U.S. & Mexico Phase 3 has been delayed, it is expected to kick off “in the coming weeks.”
All could serve as near-term catalysts, according to Mamtani.
An interim data readout from the U.K. study could get an airing possibly this month. The 5-star analyst expects NVX-CoV2373 to “demonstrate best-in-class VE & reactogenicity profile, thereby making the case for pursuing licensure across several nations globally in 1Q.”
While the U.S Phase 3 data will only be available sometime in 2021 (possibly 1H), the late stage study’s initiation could serve as an “incremental catalyst before YE20.”
Novavax could also get an additional boost from other programs’ vaccine data which did not quite attain the same lofty heights as Pfizer/BioNTech and Moderna’s offerings.
“We anticipate incremental Ph. III mixed data updates noted with AZ as well as JNJ’s single-dose JNJ-78436735 to possibly serve as tailwinds with NVAX’s global supply scale-up efforts positioning it favorably to pick up significant demand share away particularly in 2022+ timeframe when demand wouldn’t necessarily outpace supply in an effort to vaccinate several billions globally, likely on a recurring basis,” Mamtani summed up. Reference
The biotech company announced Monday that it completed enrollment of its 15,000-participant trial in the UK. Interim data from the phase 3 study is expected as soon as the first quarter of 2021. Timing is still contingent on the coronavirus infection rate in the UK, according to a press release. If successful, the data can support applications for regulatory approval in the UK and European Union.
Yet protein-based vaccines are well established, and will likely work. The most advanced for Covid-19 is from Novavax, based on the entire Sars-CoV-2 spike protein plus an immune system-activating adjuvant. However, perfecting a production system for the spike protein is challenging.
The lead vaccines, which have garnered the lion’s share of attention and funding, were not selected because they’re the best, says Nikolai Petrovsky of Flinders University in Adelaide, Australia. ‘They were just the technologies that were sitting there back in February that governments jumped on,’ he says. Faster is not necessarily better, he warns.
Most protein-based vaccines for Covid-19 employ recombinant versions of the spike protein (or parts of it), which tutors the immune system against wild virus. This works with an adjuvant, a compound that puts frontline immune cells on battle alert, thus mustering a robust immune response to the protein antigen.
In August, Novavax published positive phase 1 data. ‘The Novavax vaccine is looking outstanding,’ says Florian Krammer from the Icahn School of Medicine in New York City, US. ‘They have – so far – the highest neutralising antibody titres I have seen.’ The vaccine also provided sterilising immunity (which stops the virus replicating inside host cells) in non-human primates.