Industry Updates - Volume 7

There is a media debate as to whether the pandemic is stabilizing, or whether we are entering a dangerous new 3rd and 4th wave, driven by toxic new mutations to the virus, such as the UK, South African, and Brazilian variants. Refana's view is as follows:

​Global Pandemic

• Total deaths attributed to Covid-19 worldwide have just reached 3 million (Bloomberg). While this is a horrific total, the death rate globally may have begun to plateau.
• It took approximately 9 months to the end of September for the first 1 million deaths to occur, but just 3.5 months to mid-January for the 2nd million; and almost the same period again (just under 3 months to the first week of April) for the 3rd million.
• There is clear evidence from Israel, the UK, and early indications in the US, that the vaccine campaigns are working; even as cases continue to rise significantly in a number of US states.
• Israel has successfully implemented a major 're-opening' of the economy and large scale social and cultural events, utilising a 'digital passport' for vaccinated people.
• The EU is lagging due to its vaccine supply and logistical issues (vaccination coverage rate of just 9% in the EU so far compared to approx 26% in UK and US, and over 50% in Israel) but this is expected to be resolved by the second half of the year. Major new lockdowns are being implemented in a number of leading countries, including France and Canada.
• Worldwide we are getting close to where 5% of the population has now had one vaccine. The current rate of 16 million shots per day could cover the globe, on a two shot regime, in about 800 days. But in practice this will likely take longer, as over 70% of the current vaccinations are in just 3 large countries, China (5 million per day), India and the USA (>3 million per day each and rising).
• The Refana view is that the Pandemic will switch to Endemic status in the advanced countries, once enough vaccinations have occurred; and the focus in these countries will be on dealing with new variants and booster shots from the end of 2021. But in less developed regions, the Pandemic is likely to continue for the next 24 months, before turning to Endemic status everywhere. 
• In Brazil the pandemic seems to be getting out of control with hospitals overwhelmed, dangerous new variants emerging, inadequate supply of vaccines and over 4,000 deaths per day.
• In India the situation in a number of states in India is also extremely severe. The Indian government has banned the export of any vaccines manufactured in India until July, which will have a serious impact on many other lower income countries.

Industry and Economics

• Pfizer/BioNTech and Moderna have become the clear market leaders, especially in the advanced economies.
• AstraZeneca continues to struggle, most recently in a link established by the European Medicines Agency between the vaccine and a rare form of blood clot, that has particularly affected younger to middle aged females. While the risk is perhaps only 1/100,000 overall it may actually be 1/25,000 in the highest risk groups. Conversely the risk of death from the Coronavirus in developed economies for females aged 18 to 50 is no more than 1/20,000. Of 69 recorded cases in the EU today there have been 23 deaths. Multiple countries have now restricted the use of the AstraZeneca vaccine.
• For lesser developed countries the World Health Organization (WHO) continues to recommend AstraZeneca, but this may change as a number of African countries have announced that they will refuse to accept this vaccine. It is currently not clear whether or not AstraZeneca will continue to seek EUA from the FDA in the United States. Despite earlier announcements, no date has been set for the hearing. Meanwhile the SAGE committee of the WHO is currently reviewing the Whole Inactivated Virus vaccines from Sinopharm and Sinovac, and is likely to grant them EUA status during April.
• A small number of cases similar to the AstraZeneca blood clots have been attributed to the Johnson & Johnson vaccine. If this problem applies to Johnson & Johnson as well as AstraZeneca it may be an intrinsic problem of all Adenovirus vaccines, which includes the Chinese Cansino and Russian Sputnik V.
• In the EU significant quantities of Pfizer and Moderna are to be delivered in the coming months which will be urgently needed if AstraZeneca and possibly Johnson & Johnson will no longer be widely used.
• Russia's efforts to promote the Sputnik vaccine in Europe are running into controversy. The Prime Minister of Slovakia lost his position after the batch of Sputnik Vaccines he purchased from Russia, were found to be different to the one reviewed in The Lancet. The EMA has requested data which has not been provided. There is also a complaint that the data used in early testing did not meet ethical guidelines. The Russian Direct Investment Fund has just signed contracts with 6 Indian firms to manufacture the Sputnik Vaccines to GMP quality standard (following manufacturing problems in Russia).
• The UAE has concluded a deal with Sinopharm for technology transfer to support manufacture of this WIV vaccine by a UAE company, Group 42.
• Bharat's US partner Ocugen says they will be submitting their WIV vaccine to the FDA for EUA.
• Valneva is commencing a Stage 3 trial of its WIV vaccine in the UK, having issued a press release of positive Stage 2 results.
• Johnson & Johnson got off to a slow start after obtaining EUA due to production issues which spoiled 15 million doses in the U.S. The New York Times reported that a further 64 million doses may have also been contaminated.

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