The headlines on Wednesday, November 18, 2020 read “PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS.”
The day that everyone had been anxiously waiting for, finally arrived when the two top bio-pharmaceutical companies announced and published preliminary data suggesting the vaccine offered 90% protection against Covid-19 and said there were no safety concerns. Some facts that would be interesting to note and pretty much sum up all the important things we should know:
- Primary efficacy analysis demonstrates that the vaccine “BNT162b2” is 95% effective against COVID-19 beginning 28 days after the first dose; 170 confirmed cases of COVID-19 were evaluated. 162 were from the placebo group versus only 8 in the vaccine group
- Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94% which is a huge milestone.
- Over 43,000 participants are enrolled and no serious safety concerns have been observed; the only adverse effects seen were fatigue and headache in the worst cases.
- Safety data regulations and guidelines required to be met as per the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) are achieved.
- Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe for establishing transparency and trust
- The companies expect to produce globally up to 50 million vaccine doses in 2020 itself and up to about 1.3 billion doses by the end of 2021.
- Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to be able to distribute the vaccine around the world and meet the expectations of the people world wide.
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr. Albert Bourla, Pfizer Chairman and CEO. According to him, with hundreds of thousands of people around the globe infected and affected by Covid-19 Pandemic every day, there is an urgent need to get a safe and effective vaccine in the global market so economies can revive. “We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. This is how the vaccine is going to work:
According to the two companies, this achievement highlights the potential of mRNA as a novel, breakthrough drug class. This is going to have a very significant impact on the drug formulation and discovery for other diseases as well. But there are going to be many other aspects of the world that are going to be majorly affected, be it directly or indirectly, because of this major public breakthrough.
The most important impact will be on countries and human beings. Many countries, like Russia have been willing to roll out vaccines with only 50% to 60% efficacy in preventing COVID-19 infections. This is in an attempt to interrupt the logarithmic spread, and growth which was resulting in a high number of deaths, with other ongoing complications that come with larger numbers. A vaccine with 90% efficacy means that there is a real chance to stop COVID-19 in its tracks and drastically shorten the time it takes for life to return to normal. Most of the countries are already negotiating the buying of the vaccines.
Biggest purchases of these vaccine doses include the European Union with 200 million doses and an option for a further 100 million, the UK with 30 million doses, and the US with 100 million and an option to buy another 500 million, according to the UK-based campaign group. Even the Japanese government was able to negotiate a deal of 120 million doses in the last few days. The governments of Canada, Australia and Chile have all bought at least 10 million doses of the Pfizer-BioNTech vaccine. Access to the Pfizer/BioNTech vaccine is however going to be complicated because of the logistical challenges that comes with transporting and storing doses at -80C – as per the requirement. Many of the world’s poorer nations do not have the technology and facilities to meet this requirement, meaning they will be unable to roll out any doses of the Pfizer vaccine they do receive on the same scale as their richer counterparts. India is facing problems because of these challenges. Dr Randeep Guleria, director of All India Institute of Medical Sciences (AIIMS) Delhi, today said that India is in talks with Pfizer-BioNTech Covid-19 vaccine.
The other impact has been on the stock market. Sectors that were facing high losses – including airlines, hospitality, and energy – received a big boost. The rest of the market as well faced some serious uplifting as investors began to reassess the crisis outlook in light of a possible end to this pandemic. Pfizer’s vaccine announcement was an overall positive surprise for the market, affecting companies well outside the pharmaceutical industry. In addition to lifting the airline and hospitality stocks, the positive, headline effect however seemed to negatively affect tech stocks that have risen during the pandemic, including the stocks of companies like Zoom. Although Pfizer’s vaccine still faces many hurdles, it gives genuine hope to the global market that a return to normal is possible in the near future. Investors have also rushed to buy equities, by forgoing gold in this euphoria. Citing data from EPFR, inflows into global stocks in the last two weeks have soared up to $71.4 billion, the highest so far. This has resulted in lower gold prices.
Other than this the question still remains what unexpected impacts the vaccine will bring with it. Many are saying the side- effects will be the next biggest concerns after the logistics. Managing the reporting and follow-up of what are known as common adverse drug reactions will be critical to keeping to the high levels of public participation needed for a vaccination program to be successful. There are other mixed reactions and concerns about the fact that if vaccines traditionally take up to a decade to get to the approval stage, people wonder how can we trust the safety of one produced in a small fraction of the time. But either way, I am going to conclude by saying: Where there is hope there is life. Whatever may come next for the world, it is little pieces of hope like these that truly allow us to keep pushing ourselves through everyday life, and to ultimately discover new pieces of hope ourselves.
Written By: Preya Pandya
Sources-
- https://www.cnbc.com/2020/11/17/covid-vaccines-how-much-they-cost-whos-bought-them-and-how-theyre-stored.html,
- https://www.bbc.com/news/world-europe-54902056
- https://www.investopedia.com/pfizer-and-the-headline-effect-5087757
- https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
- https://www.livemint.com/science/news/india-s-covaxin-to-pfizer-oxford-moderna-latest-updates-about-covid-vaccines-11605841209031.html
- https://www.livemint.com/opinion/online-views/moderna-pfizer-covid-19-vaccines-side-effects-are-next-big-challenge-11605693575274.html