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With the markets positively drunk on the latest vaccine news, there is of course a litany of trade backlash.
So, in the spirit of FT Alphaville, here is the best.
First, the Goldman team:
PFE and its partner BNTX have reported positive higher Ph3 data for its COVID-19 vaccine, BNT162b2. The trial met the primary endpoint (preventing COVID-19 in people with no evidence of a previous SARS-COv2 infection) and according to the publication, the case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate greater than 90% at seven days. after the second dose. But as the study continues, the final percentage of vaccine effectiveness may vary. According to the statement, the DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned.
The data will be discussed with regulatory authorities around the world. No details are available at this stage on secondary endpoints, such as the impact on severe COVID-19. In our opinion, the data should support an Emergency Use Authorization (EUA) filing by the end of November, in line with previous EFP guidelines. In our opinion, this is positive for PFE’s actions and also strengthens our confidence in the prospects of other vaccine candidates in development. As we previewed (LINK), we believe that a higher vaccine efficacy rate at a low end of ~ 60-65% is likely to be viewed positively by investors. Dr Anthony Fauci (director of NIAID) said scientists were hoping for a vaccine that was at least 75% effective, but that 50% or 60% effectiveness would be acceptable (link).
The Vampire Squid also thinks it’s bad news for Gilead’s Remdisivir. At pixel level, Gilead is stable in pre-release.
Next, Morgan Stanley:
Pfizer / BioNTech has announced that its COVID-19 vaccine has achieved vaccine efficacy> 90% in preventing COVID infections based on the first interim efficacy analysis of 94 confirmed cases, conducted on November 8. The efficiency is stronger than expected. The PR said that “after discussion with the FDA, the companies recently chose to drop the interim analysis of 32 cases and do the first interim analysis on a minimum of 62 cases. As a result of these discussions, the number of assessable cases reached 94 and the DMC performed its first analysis on all cases. ”
Pfizer plans to submit an Emergency Use Authorization (EUA) during the third week of November, once the 2-month median safety milestone is reached. We look forward to the details of tolerance and safety, which have not yet been disclosed. The trial will continue with a final analysis of 164 confirmed cases. The trial has enrolled 43,538 participants to date, and of those, 38,955 had received a second dose as of November 8.
PR noted that there will be a new secondary endpoint evaluating efficacy based on cases accumulated 14 days after the second dose. Pfizer plans to produce> 50 million doses of vaccine in 2020 and up to 1.3 billion doses in 2021. We plan to update our financial model; please see the October 7 report titled “All Eyes on COVID Vaccine Timeline” which includes our risk-adjusted Pfizer vaccine model.
The vaccine will burn. . . .
One important thing to note is that the vaccine, if deployed, will need to be kept below minus 80 degrees. This may mean good news for companies such as 68 billion euros, listed in France, Air Liquide and $ 1.1 billion, listed in the United States, BioLife Solutions, which both specialize in maintaining this. which must be cold. (There will be more, but it comes to mind at first.)
Back on sale, and here’s the take on Cowen Investment Bank:
Our Opinion – Some questions remain, but at this stage of the trial it is an almost absolute victory. Pfizer and other companies assumed a vaccine efficacy of 60% – this data has clearly outperformed and is about as good as one could hope for at this point. Notably, the interim analysis included more than half of the events necessary for the final analysis, giving greater confidence that the> 90% efficiency will remain relatively stable.
Safety is more of an issue both because Pfizer did not provide any details in its post and because longer follow-up is needed. Still, signs of antibody-dependent improvement have potentially emerged by now, so we haven’t gone out of the woods on safety, but we’re at least going in the right direction. This victory also greatly increases the chances of success of competing vaccine candidates – great news for the company.
The risks of BNT162b2 success remain, and include: 1) there may be reduced efficacy with continued monitoring; 2) the vaccine might protect against symptomatic infection, but do a worse job of protecting against severe disease in vulnerable populations, 3) the vaccine might do a worse job of protecting against a new common variant of the virus, and 4 ) rare and / or delayed security issues could occur.
SVB Leerink says the disclosure is very promising and, more importantly, the 90% effectiveness was based on a significantly higher number of provisional cases than the 32 previously predicted. As for when to expect vaccine availability, they say Christmas is a possible target (emphasis added):
Pfizer and Biontech reiterated that they should be able to file an EUA application by the 3rd week of November. At this point, the likelihood of a major security issue occurring is relatively low. After more than 38,000 people receive the second dose of the vaccine, and are now observed for at least 7 days, the risk of serious safety events, which could interrupt the program, is likely to be low. This means Pfizer will likely get its EUA in early December, and can then proceed with labeling and vaccine distribution in mid-December, with initial vaccinations being given to those at high risk by Christmas. Pfizer’s supply will likely be limited until the first quarter of 2021 and then grow rapidly, and other vaccine companies are also expected to have their products available by the end of the first quarter or second quarter of next year. .
During this time, other data to be expected from the test are as follows:
Pfizer and Biontech confirmed that they continue to accumulate safety and efficacy data from the trial and will have the full 164 events for final efficacy analysis relatively soon (which is not surprising given the emerging infection rates around the world). This additional observation will increase the safety database and should easily exceed the FDA’s minimum two-month observation of the FDA for 50% of study registrations. This additional data should also allow sponsors to accumulate safety beyond the initial 7-day observation period, as well as to accumulate evidence of efficacy against severe COVID disease, as well as
show efficacy in a variety of racial and demographic subgroups and in individuals previously exposed to the virus. All of these will alleviate many of the concerns expressed by attendees at the recent FDA Advisory Committee meeting (see our note HERE) and potentially contribute to faster adoption of the vaccine (as it becomes available).
Don’t worry about anti-vaxxers
Deutsche Bank, meanwhile, doesn’t seem concerned about the possibility that a significant portion of the population will refuse the blow:
There is a non-linear relationship between efficacy and vaccine coverage required for herd immunity: the higher the efficacy, the lower the herd immunity threshold. Assuming an R0 of 2.5, 90% efficiency implies that governments would need to achieve vaccination coverage of around 60% to achieve herd immunity. This should be doable during 2021.
They are also optimistic about the source being Pfizer, saying that, compared to other candidates, access to this vaccine will be much wider:
Most governments in advanced economies have pre-ordered a significant number of doses; in per capita terms, the US, EU, Canada, Japan, UK, Australia and New Zealand have all pre-ordered doses sufficient to take a major step towards herd immunity to early next year. In MS, governments did not order as much, having put more of their eggs in the AstraZeneca basket. Still, Pfizer’s competitive pricing means that many governments in emerging countries will be able to purchase a significant number of doses next year.
And on the pound sterling:
More clearly, the GBP is a major beneficiary, not only because the UK government has good exposure to Pfizer in its large and extensive vaccine portfolio, but also because the UK has perhaps struggled the most to manage the pandemic without vaccine. In other words, a vaccine could make the biggest difference in the UK’s economic outlook, compared to its G10 peers.
So overall, everyone is cautiously optimistic.
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