'Great day for public health', as vaccine more than 90% effective, claims Pfizer

90% EFFECTIVE, BASED ON INITIAL DATA: News erupted on Monday (November 9, 2020) about the first reading of Phase-3 trial data of the candidate COVID-19 vaccine from Pfizer Inc. The New York-based pharma giant announced that its experimental vaccine was more than 90 per cent effective in preventing COVID, based on an interim data analysis. Pfizer earlier announced its price for the vaccine at $19.50 based on an advanced US government contract, contingent on the vaccine proving effective in clinical trials.

MESSENGER RNA VACCINE PLATFORM: Pfizer's vaccine is an anti-viral messenger RNA shot for active immunisation against COVID-19 administered as intramuscular injection. A statement released October 16, 2020 (Friday) suggested the company's coronavirus vaccine candidate could be ready for distribution throughout the US by the end of November. This May 4, 2020, file photo shows the first patient enrolled in Pfizer's COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore.

INTERIM ANALYSIS: Pfizer said the interim analysis was conducted after 94 participants in the trial developed COVID-19, examining how many of them received the vaccine versus a placebo. "I'm near ecstatic," Bill Gruber, one of Pfizer's top vaccine scientists, told Reuters in an interview. "This is a great day for public health and for the potential to get us all out of the circumstances we're now in."

PROTECTION 7 DAYS AFTER SECOND OF 2 DOSES: Protection in patients was reportedly achieved 7 days after the second of two doses, and 28 days after the first, according to initial data. Pfizer did not break down exactly how many of those who fell ill received the vaccine. Still, over 90% effectiveness implies that no more than 8 of the 94 people who caught COVID-19 had been given the vaccine, which was administered in two shots about three weeks apart.

'NO SERIOUS SAFETY CONCERNS': Pfizer and German partner BioNTech SE are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have so far found no serious safety concerns and expect to seek US emergency use authorization later this month.

VALIDATION: If a US government review board validates Pfizer's data, it is seen as the first major victory in the fight against a coronavirus pandemic. The news provides hope that other vaccines in development against the novel coronavirus may also prove effective.

WHAT HAPPENS NEXT? Pfizer expects to seek broad US emergency use authorization (EUA) of the vaccine for people aged 16 to 85. To do so, it will need to have collected two months of safety data on around half of the study's roughly 44,000 participants. That data is expected in late November. If authorised, the number of vaccine doses will initially be limited. How long the vaccine will provide protection is yet unknown.

ABOVE EXPECTATIONS: The efficacy rate is well above the 50% effectiveness required by the US Food and Drug Administration for a coronavirus vaccine. To confirm its efficacy rate, Pfizer said it will continue the trial until there are 164 COVID-19 cases among participants. Given the recent spike in US infection rates, that number could be reached by early December, Gruber said. The data have yet to be peer-reviewed or published in a medical journal. Pfizer said it would do so once it has results from the entire trial. COVID-19 has infected 50.5 million people and left 1.26 million people dead as of November 9, 2020.

HUGE CONTRACT: Pfizer stocks jumped over 40% on Tuesday following the announcement. Pfizer and BioNTech have a $1.95 billion contract with the US government to deliver 100 million vaccine doses beginning this year. They have also reached supply agreements with the European Union, the UK, Canada and Japan. To save time, the companies began manufacturing the vaccine before they knew whether it would be effective. They now expect to produce up to 50 million doses or enough vaccine to protect 25 million people this year. The company said it expects to produce up to 1.3 billion doses of the vaccine in 2021.

VACCINE MAKER: Another vaccine maker using the mRNA platform is Moderna, a Massachusetts-based biotech company, now also in advanced Phase-3 trials of its COVID-19 vaccine. Though yet unproven, mRNA vaccines had been under development since the 1990s. It essentially "trains" the human body to produce the antibodies necessary to fight the real virus when a person gets infected. As a vaccine development platform, mRNA is a relatively quick and inexpensive way to mass produce vaccines, and is theorically safer too, as it doesn't use live or killed versions of the virus used in traditional vaccine platforms. mRNA-based vaccines could make a huge impact due to their shorter manufacturing times and potential efficacy.

INJECTING A VERSION OF DISEASE-CAUSING AGENT. In a conventional vaccine, each jab injects a version of a disease-causing foreign body into the human body. This has been used for over 100 years. This method helps stimulate the production of antibodies that then fight off a version of same disease-causing pathogen, like SARS-CoV-2. A messenger RNA (mRNA) vaccine takes a different route. Compared to a regular vaccine, mRNA vaccines work by introducing an mRNA sequence — the molecule which tells cells what to build — coded for a disease-specific antigen. Once produced within the body, the antigen is recognised by the immune system. This primes your immune system to fight the real thing. In theory, that's how it works — by turning vaccine development into a software-like tweaking.

SPEEDING UP VACCINES: mRNA is seen as the advanced biopharma industry's answer to a whole new class of pathogens — or infectious agents — for which no specific vaccines exist yet. Vaccines are great, and have kept many infectious diseases at bay, saving tens of millions of lives. However, the traditional vaccine industry usually takes time to get themselves organised and develop a vaccine, typically an average of 16 years. mRNA speeds up this process. In many ways, it digitises vaccine development to enhance the human body’s own machinery to do exactly what the body does once infected.

HARD SELL: It would be a hard sell for everyone to get a vaccine. Scientists have accumulated a whole body of knowledge since Edward Jenner invented the smallpox vaccine in 1796. But social media and chat groups are rife with disinformation, fear-mongering and vaccine misconceptions that have themselves become viral. A woman draws from a vaccine vial.