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1/20/2021

Industry Updates - Volume 4

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With January nearing a close, Volume 4 looks at how the pandemic is progressing and whether vaccinations are starting to roll out.

Global Pandemic

More than 2 million COVID-19 deaths passed globally last week; More than 400K deaths in the U.S.
Latest 100K deaths in the U.S. took just 36 days from December 2020 to January 2021.
Total infections surged past 96 million, accompanied by new mutated virus strains.
CDC predicts that ⅓ of all new USA infections would be new B117 strain by March.
Ireland saw a 30X increase in infections in 2 weeks, after a 3-Day pre-Christmas loosening of restrictions.

Industry News

"U.S. Vaccination Rollout Turns to Chaos" - Latest headline story in Bloomberg 'Coronavirus Prognosis', cites last mile logistics issues with mRNA vaccines, confusion re eligibility, and not enough supply.
To address the U.S. shortage, the Federal government announced that the reserve stocks held back for second shots would be released early.
- Health Secretary Azar subsequently disclosed that no such reserve vaccine inventory actually existed.
Pfizer informed 6 EU member countries that it wouldn’t meet promised delivery dates this month and Canada has also experienced a similar delay.
Russian hackers released on the dark web negotiations between Pfizer and the EMA in December; EMA leaned against approval of the Pfizer vaccine due to quality control problems, where the minimum threshold of 55% of vaccine doses meeting the quality standard was missed, falling below 50%.
In California, the state epidemiologist called for a recall of one batch of Moderna vaccines due to a high number of adverse allergic reactions.
Deaths following vaccination are being reported worldwide. A study of 77 cases in Norway attributed it to the comorbidities of elderly nursing home population. There have been similar reports of a small number of elderly patients who died shortly post Pfizer vaccination, in both Germany and Israel.
The first death occurred in India following vaccination with The Serum Institute of India (SII) produced AstraZeneca-licensed vaccine, and is being investigated.
In the 'data wars' Sinovac’s vaccine came under fire for varying estimates of efficacy from 51% to 78%, based on different trials and measurement methods.
- The lowest figure occurred when Sinovac was required by Brazilian authorities to count vaccinated parties with no symptoms of Covid but some evidence of presence on a clinical test.
- Company officials claim this measurement is inconsistent with the method used in other companies, trials, and that their vaccine was 100% effective against serious disease.
- Nevertheless, Brazil has since confirmed its authorisation and purchase of the Sinovac vaccine.
The Times of London lent credence to this criticism by claiming that the 95% efficacy quoted for Pfizer had ignored cases with only mild symptoms.
- The same article also suggested that Pfizer might be 50% effective after one only dose.
- Pfizer did not PCR-Test those with mild symptoms, and cannot say that they were not infected.
However in Israel the largest HMO, Clalit, released a study comparing 200,000 each of vaccinated and unvaccinated parties (10 times the size of the Pfizer Stage 3 trial) after one dose of Pfizer, and concluded that one Pfizer shot was only 33% effective.
In view of the shortage of vaccines and logistical challenges, regulators in both the United States and Europe are rushing through the approval process for the AstraZeneca and Johnson and Johnson vaccines in the coming weeks.
Rajeev Venkayya - A leading industry figure - Global Head of Vaccines at Takeda; former Head of Global Healthy delivery at Gates’ Foundation; and previously Senior Director for BioDefense at the White House - Called for an end to the 'data wars’, saying all approved vaccines so far appear equally effective in providing close to 100% protection against severe Covid.
- The relevant, but currently unknown, differences between vaccines were length of protection afforded and effect on transmissibility.

Financial News

A leak by a Belgian government Minister disclosed the prices negotiated for vaccines in the EU:

Value	Price to EU
Pfizer/BioNTech	€12
Moderna	$18
AstraZeneca/Oxford	€1.78 (might be at cost)
Bayer/Curevac	€10
GSK/Sanofi	€7.56
Johnson & Johnson/Janssen	$8.50

Israel is paying $47 per two dose regime, and appears to have secured early access to supplies from Pfizer (and soon from Moderna).
- By combination of paying higher prices, and sharing its comprehensive data capture, from its high speed rollout (80% vaccination of older and high risk groups/25% total population vaccinated).
WIV vaccines from China are gaining wide acceptability in the Muslim world. Indonesia, Bahrain, Saudi Arabia, Bangladesh, Malaysia, UAE and Pakistan have all approved WIV vaccines.
- The highest religious authorities in Indonesia (the world's largest Muslim population, and 4th most populous country overall) have declared Sinovac to be Halal.
- A Halal issue may arise with the AstraZeneca vaccine - a stabilizer component was originally derived from Pig gelatin, commonly used as a vaccine feedstock component.
The Chinese vaccines are also moving into eastern and central Europe. Following previous deals in Turkey and the Ukraine, Sinovac has now been ordered by Hungary and Sinopharm by Serbia.

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1/4/2021

Industry Updates - Volume 3

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As we enter 2021 Volume 3 reviews Emergency Use Authorization approvals as the world scrambles to vaccinate as quickly as possible.

Pandemic 2021

We enter 2021 with the Covid pandemic in a third and even larger surge worldwide, with many countries enforcing unprecedented lockdown measures.
Globally confirmed infections are likely to exceed 100 million, and 2 million deaths, by month end. This compares with 50 million cumulative confirmed cases in the first week of November, and just over 1 million cumulative deaths at the start of October - a doubling of cumulative deaths in approx.100 days.
There is now a worldwide scramble to vaccinate as quickly as possible, as the emergency use of a number of vaccines is approved, against a backdrop of a global shortage of vaccines, and a loosening of previously inviolable medical and regulatory standards.

Industry News

Following the FDA granting Emergency Use Authorization (EUA) for the Pfizer BioNTech and Moderna vaccines in mid-December, there has been a rush to approve these and other vaccine candidates in other countries.
The UK and India both granted EUA to the AstraZeneca Oxford vaccine, despite issues with the Stage 3 trials.
India also gave conditional approval to the domestic Bharat Biotech’s Covaxin WIV vaccine, notwithstanding incomplete Stage 3 data.
Dr Slaoui said on CBS Face the Nation that there are discussions with the FDA re cutting the Moderna dose in half for the under 55s to increase availability. This is based on some limited data from the Stage 1/2 trial, but this protocol was not tested in the Stage 3 trial.
China gave the first general public use authorization of any vaccine worldwide to the Sinopharm WIV vaccine. China says that 4.5 million vaccinations have already been given in China, and set a target of 50 million vaccinations by Chinese New Year on February 6th, at a current rate of approx 1 million per day (or about 70 per 100,000 per day).
A number of major countries are now approaching vaccination of 1% of their population. Among smaller countries Israel has vaccinated 10% of its population, and Bahrain is reaching 4%. Many countries have experienced significant distribution and logistical issues even when vaccine supplies are available. In the US 14 million vaccines have been distributed to date, but only 4 million administered.
Daily rates of vaccination per 100,000 in late December have been 608 in Israel, 263 in Bahrain, 60 in the UK, 49 in the US, and 10 in Canada.
Vaccine efficacy reported from official Stage 3 trials is 94/95% for mRNA - Pfizer and Moderna; 79% for WIV - Sinopharm; and 62% for Adenovirus - AstraZeneca Oxford. (The British regulators did not accept AstraZeneca’s claim of a higher rate as statistically valid, and did NOT approve a half dose/full dose regime which accidently produced this result in a small sample of younger healthy people.)

Dr Fauci has revised his estimate for herd immunity upwards from 60-70% to 70-80% of the total population.
The new British mutation of the dominant G strain has now appeared in many other countries. Vaccine manufacturers are hopeful that the current generation of vaccines, all developed against the original D strain, will still provide protection, but acknowledge that updated versions may become necessary in the future.

Financial News

Valneva, the French company developing a WIV vaccine with support from the British government, has announced plans for a US IPO.
The Ukraine announced the purchase of 1.9 million doses from Sinovac, at a price of $18 per dose.
The Serum Institute of India (SII) is finalizing a sale of 100 million doses, that it is manufacturing of the AstraZeneca vaccine, to the Indian government at just under $3 per dose, but said its price for commercial sales will be 5 times higher (approx $15 per dose).
Hong Kong has announced plans to acquire 7.5 million doses each of Pfizer (mRNA), Sinovac (WIV) and AstraZeneca (Adenovirus), and to allow consumer choice of vaccine.

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Industry Updates - Volume 4

Industry Updates - Volume 3

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