On Monday, we witnessed one of the craziest days on the market in recent history.
What was going up suddenly went down, and what had looked down and out jumped up and came back alive.
The trigger was the landmark news that Pfizer and Biontech’s Covid-19 vaccine candidate had sailed through its first interim efficacy analysis.
The idea that the world’s could see an effective form of pandemic protection roll out before year-end sent global stock markets higher, lifting sectors all the way from airlines to retailers.
The BNT162b2 vaccine candidate in question is based on BioNTech’s proprietary mRNA technology, and it is supported by Pfizer’s global vaccine development and manufacturing capabilities. It works by encoding an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is a target of virus neutralizing antibodies.
Pfizer’s vaccine candidate is currently being evaluated in a global Phase 3 study, which is ongoing at more than 120 clinical sites worldwide, including the United States, Brazil, South Africa and Argentina. To date, the trial has enrolled some 37,000 participants, with more than 28,000 having received their second vaccination.
It seems likely that BNT162b2 will be the first Covid-19 vaccine to reach the market in the West. However, it should be remembered that, so far, we have only seen a brief glimpse of the results.
A more detailed breakdown of the data remains crucial, while safety too has yet to be confirmed. After all, even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000.
The commercial potential of the vaccine remains unclear, and we will only have more visibility once the durability of protection is confirmed. Any vaccine allowed for emergency use will still be experimental and subject to ongoing review.
The question is, do these preliminary results truly warrant such a reaction from the market?
We know that after the elections and latest round of QE that there was a huge amount of money waiting on the side lines to be deployed. These vaccine results provided the perfect opportunity to deploy and the market responded spectacularly (crashing two prominent UK investment platforms in the process).
But was this response the signal of the end of the pandemic?
Are the results really the game changer that will get the world turning again?
That’s a different question entirely.
Pfizer’s initial press release did not discuss the extent to which the vaccine prevents severe disease, the efficacy in the most patient groups, the ability to transmit the virus, or how long its protection lasts. More importantly, it did explain what will happen if/when the virus mutates.
Without knowing this vital data, we are still in the dark.
The real question is one of trust. Will the public trust the vaccine enough to use it?
The Pfizer vaccine also relies on a still-unproven technology involving genetic material known as messenger RNA, or mRNA. When that mRNA is injected into the body, it prompts cells to make copies of the coronavirus’ spike protein — which prompts the immune system to begin churning out antibodies. But do we know enough about the safety profile for a mass rollout?. The Pharma cos have been given indemnity from prosecution for the fast-tracked vaccines should anything go wrong.
Remember, it was Pfizer- the world’s biggest drugmaker – that was slapped with fines totalling US$2.3 billion by the U.S. government after being deemed a repeat offender in the pitching drugs to patients and doctors for unapproved uses.
That was one of the biggest criminal fines ever.
Meanwhile. many people will have reservations about using a vaccine that has been rushed through at such incredible speed without a full safety profile. This will be a real bottleneck, if and, when we get approval, manufacture and distribution of any vaccine.
Would you buy a car from a manufacturer which had been sued for unethical and unsafe practices and were exempt from any future liabilities?
If Pfizer is so confident about the safety vaccine and recommend the public ‘en masse’ to use it, would it be prepared to accept responsibility if anything went wrong?
Dr Kellow’s (from NHS Nightingale faculty) social media survey suggests over two thirds will not use the vaccine.
Will you have the Pfizer vaccine? If not, why not.
(Please share so we can get a representative response).
— Dr Nigel Kellow ? (@NigelKellow) November 10, 2020
Similarly, a recent poll by the Associated Press shows only 46% of those surveyed want to get a COVID-19 vaccine, while another 29% said they were unsure.
The FDA told vaccine makers last month not to seek speedier-than-normal review until they had tracked at least half their trial volunteers for two months. With other vaccines, that’s when major side effects begin to crop up around half of the time.
But that two-month follow-up period for side effect tracking isn’t long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. Remember that the initial completion date of the study is 11 Dec 2022, with the primary completion date being 13 June 2021 and here we are in November 2020 preparing for a mass rollout, no wonder people are anxious about the vaccine.
ECRI’s Dr. Marcus Schabacker said the FDA should require six months of follow-up. “Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”
For example, Sinovac Biotech’s Covid-19 vaccine tests were showing promising signs. The firm’s experimental “CoronaVac” had been gaining traction after preliminary results found that the injection appeared to be safe. The company inoculated thousands of its own employees and their families as part of China’s emergency programme. But late last Monday, the country’s health regulator suspended testing after a “severe adverse effect” that took place on Oct. 29. We hear similar stories with the Astra Zeneca and J&J vaccine trails.
Even if a vaccine is found to be effective and safe and is authorized within months, it will initially only be available to a tiny percentage of the American public, never mind the global population. Some 50 million doses (25m people) are projected for Dec 2020 with manufacturing increasing to 1 billion doses (500 million people compared with the global population of 7 billion) by end 2021.
Even then, there is still no data about whether a vaccine will stop the asymptomatic spread of the virus, how long the protection actually lasts for, the extent to which it will prevent people from developing severe Covid-19, or what protection it affords to the most vulnerable patient groups.
The final barrier that Pfizer must overcome is distribution, given that BNT162b2 must be transported and stored at -94C. bearing in mind that your home freezer may reach -30C, and most clinicals do not have capacity, this could prove to be a logistical nightmare. The challenge is by no means insurmountable, but it will certainly be very difficult for those in developing nations.
With limited supplies available until next year and two shots needed to complete treatment, Pfizer’s vaccine won’t end a rampant pandemic overnight.
In conclusion, the results do not point towards a near-term solution, with many questions and challenges remaining.
That being said, there seems to be a glimmer of hope and a light at the end of the tunnel. As markets are forward thinking, this week’s surge is mostly likely due to the prospect of a vaccine becoming a reality sooner rather than later than the Pfizer vaccine itself being the silver bullet.