There is a light at the end of the tunnel.
On Monday morning in the US, Pfizer said its COVID-19 vaccine prevented 90% of infections in a large scale study comprised of tens of thousands of volunteers. It was the most significant scientific breakthrough of the pandemic. There were no serious safety issues.
US equities were already poised to build on last week’s extraordinary post-election gains. The Pfizer news injected (no pun intended) rocket fuel into the rally. Russell 2000 futures surged some 7% on the news.
The study enrolled more than 43,500 participants. Safety and additional efficacy data continue to be collected, the company said Monday.
A submission for Emergency Use Authorization to the FDA is planned for “soon after” the required safety milestone is achieved. Pfizer said that is expected in the third week of November.
The press release leaves little room for equivocation. “Today is a great day for science and humanity,” Pfizer CEO Albert Bourla said. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen.”
This comes as European leaders were forced to take their countries back into stringent lockdowns amid aggressive outbreaks of the virus. US cases topped 10 million over the weekend, and daily cases recently exceeded 100,000.
“With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis,” Pfizer went on to say, adding that “protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.”
This is fantastic for cyclicals and other equity expressions that lagged last week during the post-election rally. Bond yields surged on the news. You can probably expect huge underperformance from tech and “stay-at-home” stocks.
“This is about the best the news could possibly be for the world and for the United States and for public health,” William Gruber, Pfizer senior vice president for vaccine clinical research and development remarked.
The pro-cyclical rotation that failed to pan out due to Democrats’ underperformance in congressional races last week will likely get new life. And with the obligatory caveat that such rotations have a tendency to stall and otherwise flame out, this is the kind of news that could be a game changer.
Whatever the case, it adds to the good vibes on a day when the world was already predisposed to optimism following Joe Biden’s victory speech over the weekend.
From Pfizer
NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE)– Pfizer Inc. and BioNTech SE today announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201109005539/en/
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. 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 worldwide.
“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavor,” added Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech co-founder and CEO. “When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”
The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms.
The companies have posted an updated version of the study protocol at https://www.pfizer.com/science/coronavirus.
Pfizer and BioNTech are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate — the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization — will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.
This is fantastic news. I can’t wait to be able to go out for dinner at a nice, sit down restaurant.
Not to throw cold water on this celebratory moment but I find these results to be at least slightly misleading. The only way to empirically determine the efficacy of this vaccine would be to inoculate candidates with the vaccine and then inoculate them with Covid-19. If 90% of those who received the vaccine did not become infected with Covid, then I would agree that the vaccine could be called 90% effective. However, in Pfizer’s case, they inoculated candidates with the vaccine and then relied on pure luck to determine the efficacy of the vaccine? How many candidates were even exposed to Covid during this trial, do we have any idea? What if 90% of the vaccine candidates never even came in contact with Covid during the trial? Would that equate to the 90% efficacy rate that they are touting? Now I’m not suggesting that the vaccine is completely ineffective, but what I am saying is, we don’t actually know how effective it is.
I’m not sure your characterization is 100% accurate. In the interest of transparency, I’ve added the entire Pfizer press release to the bottom of the post. It contains links to the relevant study information. It’s not a matter of “cold water,” it’s a matter of saying things in a public forum and being sure they are 100% accurate. I’m not suggesting you’re wrong, I’m just saying that, as part of our ongoing efforts to ensure the integrity of the information presented on this site, comments that contain assertions that may not be 100% factual may be flagged as such going forward.
Flag me all you like, I’m not trying to incite panic but what I am saying is read Pfizer’s own definition of done and then tell me that they are being responsible in reporting what they did today.
4.4. End of Study Definition
A participant is considered to have completed the study if he/she has completed all phases of
the study, including the last visit. Note that participants enrolled in Phase 1 in groups that do
not proceed to Phase 2/3 may be followed for fewer than 24 months (but no less than
6 months after the last vaccination).
The end of the study is defined as the date of last visit of the last participant in the study.
To add some levity to this discourse, and perspective. It’s about the most Trumpian thing I’ve ever seen a pharma company do to declare victory 6 months into a 24 month trial by claiming it’s 90% effective.
“This is the most successful vaccine in history!”
Yeah I have to agree that it is vastly premature and the sample size far too small to give any confidence to a 90% number. If it’s generally well tolerated it is probably worth going forward with inoculation while maintaining masks and see what happens because ultimately that’s how you are going to get robust data. Even 30% effective it would be something to bring down the spread and we’re in need of a lot of help the way things are going.
Well I agree that any efficacy (without harmful side effects) is good. What we don’t know yet, is at what cost are they going to provide this vaccine and, how long does this immunity last? Being a virus and their predisposition for mutation, by the time we get this thing to market, the virus may have already mutated beyond the RNA sequence that they are leveraging to identify it. This has actually already occurred once since the virus was discovered in the spiky proteins that it uses to attach itself to cells.
https://www.cell.com/cell/pdf/S0092-8674(20)30817-5.pdf
Once the information was known to the Pfizer community, I would rather they get it out there than become the subject of insider trading. Can you imagine the smoke coming out of Trump’s ears when this came out after! the election?
I think at this point Trump is more concerned with how to avoid being a “loser” and how to avoid being prosecuted for the myriad crimes he and his administration have committed the past 4 years.
cd, I would expect they were a little more scientific than that. Perhaps they meant a 90% reduction of illnesses versus expectations, and possibly in high risk populations or some other ways of measuring effectiveness. Vaccine science has been around a long time, and I wouldn’t expect Pfizer to make such a gaffe.
I doubt it’s a gaffe, it’s technically a meaningful number just not necessarily the meaning people might first ascribe to it. It is ultimately good news even is slightly misleading. Given that it’s going to be a challenge to get people to take it with a 28 day inoculation double dose regimen you may as well get people excited. It’s just if I were making trades on the information I would be taking note that this may not be a silver bullet but it should prove useful anyway.
I’m not saying that they are not being scientific in their approach, what I’m saying is that it is way too early for the science to come to the conclusions that they are reporting. You can’t declare a study successful before it’s completed. And you also can’t declare 90% efficacy when you have no idea how many candidates have even been exposed to the virus to determine who should and should not have been infected by the virus.
This is purely a marketing stunt to get their vaccine approved and to market first so they can rake in the profits from a desperate global population ready to be done with this pandemic.
Good day to already be in the market. 😂
I do not know anyone who wears a mink coat, but I still would like to see a vaccine for the millions of mink that Denmark is about ready to kill due to them bring infected with transmittable (to humans) covid.
I agree, this is not over, but great progress for mankind.
This is wonderful news! Also, perfect timing by Marko Kolanovic again. Mr. White’s Friday article was prescient:
“We expect an end in sight for the COVID-19 pandemic,” he wrote Friday. He cites the “imminent arrival of positive vaccine news (e.g. days/weeks).”
So, from a national standpoint, when will an effective vaccine have been given to enough of the population that Covid won’t be a factor in the health of the economy?
Gad to see some success on the vaccine front, but I’m under no illusion that this is going to be any kind of magic bullet. Even the small-pox vaccine took almost 200-years to get rid of small pox. A 90% effective vaccine cannot eliminate this virus…especially when there is sure to be many, many anti-vaxers that will refuse to take it. Don’t trade on the news cycle.
I wonder how conspiratorial-minded Republicans are taking the timing of this news and market reaction.
About like you’d expect. A few have posited a conspiracy already, and they’ll be more. But, even if it’s true, I suppose what I would say is that it wouldn’t exactly reflect well on the administration.
Hi H: you know I am a little crazy…. I looked up the political contributions made by Albert Bourla (CEO of Pfizer) almost right away…..mostly to Republicans. Not conclusive evidence, but evidence nonetheless.
He was just covering his tracks… 😉
44,000 people were in the study…..half were given a placebo. Out of those 44,000, about 95 people
were infected by Covid……and extrapolating the data, it sounds like about 90 of those infected
were taking the placebo.
The vaccine would be considered effective if 55% were protected…….90% is a spectacular number.
Plus they are saying there are minimal side effects. This is great news and is likely to enable
the country to get back to normal after about half the country is inoculated, which should be by this spring.
From what I have read, “by this spring” is ambitious given the heavy duty issues with distributing a vaccine that needs to be kept at 70 below zero. Despite Pfizer’s production of an appropriate shipping container, most retail drug stores and many regional (read rural) hospitals & clinics are poorly equipped to handle it.
Hopefully one or two side effect horror stories will not emerge which will give credence to the large numbers of anti-vaccers out there. Polling I saw indicated that anywhere between 25 and 40% of respondents were unlikely to opt for any vaccine. But those surveys were done before Covid spread to the south and midwest. Perhaps there will be more take-up now that Trump country has been ravaged as well.
The first 95 people infected by Covid, no telling what that number will be in a week, a month or 6 months. No telling how long a vaccine will keep someone safe. And, it’s known that the virus mutates and there’s no telling how that will impact efficacy. It’s much too soon to be jubilant.
Regarding the trial data: there are thousands of highly-trained people employed in the global pharmaceutical industry, whose job day-in and day-out is to develop experimental treatments (drugs, vaccines), design clinical trials for statistical rigor, and analyze trial results. Trials for a new investigational agent like the Pfizer trial (and the Moderna trials, J&J, Novavax, Innovia, AZ, Sanofi, etc) are reviewed and approved by regulatory authorities, i.e. FDA, EMEA. While there has been a fair bit of shady science and poor clinical trial design in the COVID era, this has been in the realm of investigator led studies, not those carried out by established pharma companies. Suffice it to say that the Pfizer clinical trial design is sound, you don’t need a challenge trial to get valid results. Is five months of data ideal? Of course not, and nobody plans to stop collecting data at 5 months. But the data that has been collected (full of caveats, of course) is promising, as has been amply discussed above and in the media.
As for motivations, insider trading, etc. Pharma companies and biotech companies are continually running trials and collecting data that can have an impact on the finances of the company, and thus the stock price. Not that insider trading can’t occur, but you’d be pretty stupid to do it if you are an employee. To put the financial stakes in perspective, Pfizer will make a few billion dollars profit from this vaccine over the course of a few years–probably–and I say probably because there are many vaccines in development that might turn out to be better (certainly easier to store and transport), and Pfizer’s window for selling the vaccine could be short. Furthermore, there is great pressure not to gouge the world on this therapy, and all eyes are watching. This will likely not even be Pfizer’s leading product in the year of maximum sales. The motivations of the pharmaceutical industry are multifaceted here: yes, they want to make a profit, but more than that, they see an opportunity to show the world how much value they can add, they want to preserve their business model of being able to profit comfortably on an on-going basis from drug/vaccine development. That’s at the industry level, but at the company level, and the individual researcher level, there’s a huge amount of pride on the line: to prove that what they do is valuable, and even, to try to help out the world.
The timing of vaccine data release should never have been a political issue. I don’t believe it is in other countries besides the US. But here in the US we have a president who lives on the patronage model, who tries to claim everything good as his, who has vilified science and scientists, and who has, through his direct role in leading not just an ineffective pandemic response, but a counter-effective pandemic response, contributed to probably 100,000 or more unnecessary deaths in the US alone. I doubt that Pfizer held up their data release deliberately until after the election, but it doesn’t bother me that Trump doesn’t get to profit from it.
Thanks Joey. Some great insight there.