With a slight relief, the world received a good news on Monday as pharmaceutical giant Pfizer and German partner BioNTech announces a 90% success in their vaccine trial against Covid-19.
It was the first encouraging result for any stage-3 vaccine trial ever conducted which has brought the medical team and the public a glimpse of hope for the fight against the virus. But it’s fairly important to know that the result is still preliminary, and there are still a lot more we need to know how well the vaccine works.
One thing’s for sure: The vaccine will not come in time to rescue the world in the next several months, whilst the virus will claim more lives unless the public takes tougher public health measures.
What we know so far
- Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
- Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
- Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
- Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
- Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints
View the full release here: https://www.businesswire.com/news/home/20201109005539/en/
Is the Pfizer vaccine safe?
So far Pfizer and BioNTech have reported no serious safety concerns from their vaccine. Before running the current large-scale study, the companies ran smaller clinical trials starting in May that were specifically designed to detect warning signs about the vaccine’s safety. They tried out four versions of their vaccine and selected the one that produced the fewest cases of mild and moderate side effects, such as fever and fatigue.
If their vaccine receives an emergency authorisation from the FDA and gets distributed to millions of people, the Centers for Disease Control and Prevention and the FDA will monitor them to make sure there’s no evidence of even rarer safety issues. Participants in the trial will also be monitored for two years.
Who will get the new vaccine first?
Pfizer’s chief executive has said that it could have 30 million to 40 million doses of the vaccine before the end of the year, enough for 15 million to 20 million people to get an initial shot and a booster three weeks later.
Exactly who will qualify for the initial doses has not been decided, but groups that are at higher risk for infection, or are more vulnerable to the virus, are likely to get priority. That could include health care workers as well as older adults and those who have risk factors like obesity or diabetes.
Pfizer and BioNTech say they could ramp up to 1.3 billion doses a year. That’s still far from enough to satisfy the world’s need for vaccines. If other vaccines also prove effective, companies will be able to manufacture them as well and help meet the demand.
When will the general public be able to get it?
Pfizer has said that it will likely apply for emergency authorisation in the third week of November, after it collects the two months of safety data that the FDA has asked manufacturers to submit. Then, the agency will consult with an outside advisory committee of experts, and may take weeks to pore over detailed data about the vaccine’s safety, effectiveness, and the companies’ ability to safely manufacture millions of doses.
The vaccine could be authorised for certain high-risk populations before the end of the year, but that would only happen if everything goes as planned and there are no unforeseen delays.
What is left to do in the trial?
The trial will continue until it reaches 164 cases of Covid-19. At that point, the study will be complete and the results analysed.
While the preliminary results offer some compelling evidence that the vaccine is effective, they don’t tell us with certainty just how effective it is. Clinical trials simply aren’t set up to do that. They can only allow scientists to make an estimate based on statistics — an estimate known as efficacy. The effectiveness of a vaccine can only be firmly determined once millions of people get it. But experts say that the preliminary data indicates that the effectiveness should be very high.
Will it work on older people?
The new results also don’t tell us whether older people will get strong protection from the vaccine. Pfizer and BioNTech’s clinical trial includes people over age 65, so it will eventually provide this crucial information. Early clinical studies have suggested that older people produce a weaker immune response to coronavirus vaccines. But with such strong preliminary evidence, it’s possible that they will still get strong protection from a vaccine.
What about children?
Another open question is whether children will get protection from the vaccine. The trial run by Pfizer and BioNTech initially was open to people 18 or older, but in September they began including teenagers as young as 16. Last month, they launched a new trial on children as young as 12 and plan to work their way to younger ages.
What does this news mean for the other vaccines in the race?
There are 10 other vaccines now in late-stage trials across the globe. The fact that Pfizer and BioNTech have gotten encouraging results is making experts optimistic about the entire field.
“It gives us more hope that other vaccines are going to be effective too,” said Akiko Iwasaki of Yale University.
Original WRITER: New York Times
Sources: www.Pfizer.com/news/press-release | Bangkok Post
