There was a collective sigh of relief around the world on 9 November, when drug-maker Pfizer and its partner BioNTech revealed that their COVID-19 vaccine candidate was more than 90 percent effective in preventing the infection.
With the flurry of excitement, a lot of key questions were left unanswered. We break down all you need to know.
What did Pfizer and BioNTech reveal?
The companies have shared partial information from the clinical trial based on the first formal review of the data by an outside panel of experts. While the phase 3 trials are still ongoing in the US, no adverse safety concerns have been observed so far, the company said, according to a report by The New York Times.
The trial has enrolled 43,538 volunteers and 38,955 have received their second dose.
They would be seeking emergency authorisation of the vaccine later in November after collecting two-month safety data, as per the recommendation. Pfizer would be looking at manufacturing doses for 15-20 million people, according to company executives.
“I’ve been in vaccine development for 35 years. I’ve seen some really good things. This is extraordinary. This really bodes well for us being able to get a handle on the epidemic and get us out of this situation.”William Gruber, Pfizer’s senior vice president of vaccine clinical research and development
Should this give us hope?
Yes, because it’s a great result, especially to develop a vaccine with such efficiency in the same year as a pandemic.
Also, 90 percent efficiency passes the bar of The Food and Drug Administration, who had said that vaccine candidates need 50 percent efficacy for emergency authorisation, reported The New York Times.
Ninety percent is amazing, and to get a sense of this, remember that the influenza vaccine is only 40-60 percent efficient – but that is because the influenza virus keeps evolving. We don’t know yet if COVID-19 will behave like that.
According to the US’ Centers for Disease Control and Prevention, one dose of MMR vaccine is 93% effective against measles, 78% effective against mumps, and 97% effective against rubella.
How can we so sure about this vaccine? Is it safe?
While these developments are exciting, some questions remain.
The announcement reveals only sparse findings from the late-stage trial.
Specific information - on whether the vaccine prevents critical cases, or whether it prevents people from carrying the virus without symptoms, or for how long the vaccine can provide protection to a person - is still unknown.
Data from earlier did show that the candidate causes side effects such as aches and fevers.
Therefore experts warn against reaching any conclusions before deciding on the efficacy and safety of the vaccine.
As FIT has previously explained, vaccine development is a long process, and while we are currently witnessing record-breaking speed, all the necessary steps need to be followed diligently before one is put to use.
Pfizer also needs to test its efficacy on various groups of people – like the elderly and children. Older adults have weaker immune systems and responses to vaccines, but the trial does include adults over 65 so the results will be telling.
As for children, the trial initially had only those above 18, but in October they started a new trial with children aged 12 – and they want to go younger. Children are a specific and vulnerable population with “specific ethical and clinical concerns,” says the WHO.
What needs to be done before it becomes available?
Vaccine development is a lengthy process to ensure the utmost safety. Beyond the research and clinical stages, the results also need to be analysed, peer-reviewed and independently vetted.
The Pfizer trial will continue until it reaches 164 cases and then they will close the study to analyse the results.
It’s important to note that these preliminary results cannot tell us how effective the vaccine is, they just provide very good evidence that it might be and this estimate is known as efficacy.
Whether this actually works, and if it is really effective, can only be known after many, many people try it. Experts say it should work well, but we can’t know till we try it.
Who will get the vaccine first?
The big question and it still remains undecided. According to NYT, Pfizer’s chief executive said they could have 30 to 40 million doses of the vaccine before the year-end which is enough for around 15 to 20 million people to get an initial shot and a booster three weeks later.
But who qualifies for this dose? No one is sure yet.
It’s most likely the most vulnerable groups – like the elderly with co-morbidities or frontline healthcare workers - will get priority.
The firm adds that they could manufacture 1.3 billion doses a year - but this still falls woefully short for the entire world. The bright side is that if the vaccine does prove to be effective, other companies can help with the manufacturing to meet the demand.
How does the mNRA vaccine work?
The technology in use is relatively new - it involves using genetic material from the virus called mRNA. This method has not been used to create a vaccine so far.
It uses a genetic platform called mRNA, short for messenger RNA, which directs the body’s cells to stimulate the immune system.
Moderna, one of the other frontrunners in the vaccine race, is also using an RNA vaccine and is also in phase three trials.
What about other vaccines in the COVID-19 race?
According to the WHO, there are 47 candidate vaccines in clinical evaluation and 10 of these are in phase 3 or late-clinical trials.
Akiko Iwasaki of Yale University told The New York Times:
“It gives us more hope that other vaccines are going to be effective too.” said
The success of Pfizer and BioNTech could be encouraging to other drug companies - and besides, if it works, it would be great for the global healthcare industry as they would have to step in to help manufacture and meet demand.
Is everything normal now? Can we ditch social distancing and wearing masks?
No! The COVID-19 pandemic is far from over, and India has 85,91,730 total infections, with 38,073 infections in a day reported The Ministry of Health on Tuesday, 10 November.
The coronavirus death count climbed to 1,27,059 with 448 new fatalities.
Besides, even if all goes well and the vaccine is developed, it will first go to a small section of the American public, then a larger section, and then the rest of the world. Even within that, each country will decide who gets the first dose, and it will likely be the most vulnerable groups.
Most importantly, the data is not clear on if the Pzfier vaccine can stop the asymptomatic spread or prevent deaths from severe COVID-19 cases. So mask up!
Experts say that even with a vaccine, additional measures like masks and distancing will still be important and necessary - until there is no threat to public health anymore.
Talking to The New York Times, Dr Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s vaccine advisory panel, said,
“This will not replace hygienic measures — it will be an adjunct to hygienic measures. You owe it to others to make sure you wear a mask”Dr Paul Offit
So while this is great news on the vaccine front, it’s not time to let your guard down yet!
(This article was first published on FIT and has been republished with permission.)
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