Based on preliminary results, Pfizer and BioNtech announced on Monday that their coronavirus vaccine works in nine out of 10 cases and that they will begin procedures to seek its emergency approval.
The companies reported that their compound, which like nine others is in phase 3 clinical trials, has been tested in 43,500 people without detecting any major adverse effects.
Although the news offers hope in the fight against the pandemic, the scientific community has warned that it is necessary to be cautious, and that it is necessary to have complete data from the studies before we can definitively assure that the vaccine is safe and effective to be massively distributed.
The preliminary results published by Pfizer and BioNtech is what experts call a “interim analysis”, as explained by bioengineer Harry Al-Wassiti and professor of pharmaceutical biology Colin Pouton, both from Monash University; and Kylie Quinn, a biomedical science researcher at RMIT University in Australia.
An interim analysis is “a first look at the data before the study is completed to understand if there is any indication that the vaccine may work,” these researchers write in an article in The Conversation.
They also caution that only one press release is known so far, that the data has not yet been peer-reviewed, and that when the study is completed the estimate of efficacy may vary.
Anyway, several questions arise after the announcement. These are the answers to some of the most common.
1. How does the vaccine by Pfizer and how effective is it?
The vaccine is designed to teach the immune system to fight the coronavirus.
It is a new type of vaccine called RNA, which uses a small piece of the virus’ genetic code.
Upon entering the body, the immune system recognizes the external agent and begins to attack it.
The vaccine is given in two doses, separated by three weeks, and preliminary data suggest that protects more than 90% of people developing symptoms of covid-19.
It is important to clarify that there are no RNA vaccines that have been approved for use in people.
This concept has been previously investigated and these types of vaccines have been provided in clinical trials to treat other diseases.
The vaccine will be reviewed by regulatory agencies around the world, which will decide whether the dose can be approved for use.
2. Who will get it first?
The companies said that if all goes well they have the capacity to manufacture 1.3 billion doses by the end of next year, but they could partner with others to further increase production.
In several countries it is said that the first to receive the vaccine would be the risk groups, for example, the elderly, since the age is one of the biggest risk factors for the disease.
It has also been proposed that health personnel be among the first groups to receive it.
There are still steps before the vaccine can begin to be distributed, but it is known that several countries had negotiated pre-agreements with Pfizer for the supply of doses, as in United States, United Kingdom and España.
In Latin America, countries like Mexico, Ecuador and Peru they already communicated their pre-agreements with Pfizer and other pharmaceutical companies that develop anticovid vaccines.
Waiting times may vary depending on the region and logistics, but most countries are confident that the first vaccination campaigns will have started by next spring.
3. What challenges do you face for your distribution?
If the vaccine is approved, the achievement of distribution goals depends in large part on solving a logistical challenge related to the temperature at which the compound must remain.
The Pfizer and BioNtech vaccine belongs to a class of vaccines called “ultrafrías”, because they must be transported at temperatures below -70º C.
Most other vaccines do not require such low storage temperatures.
This represents a challenge, as many countries and rural areas do not have the proper equipment to reach those temperatures.
Ultra-cold storage can be an obstacle even in the most sophisticated hospitals in the United States, according to Reuters.
“The cold chain will be one of the most challenging aspects of administering this vaccine,” Amesh Adalja, principal investigator at the Johns Hopkins Center for Health Security, told Reuters.
4. ¿Give to lasting protection?
It is impossible to know and only time will give the answers.
If immunity is not durable, it will be necessary to be vaccinated every year, in the same way as against the flu.
The available data also did not show whether protection against COVID-19 is the same in all age groups. However, preliminary studies suggest that both the young and the elderly generate immune responses.
There will also be people, such as those with a weakened immune system, who will not be able to receive the vaccine.
5. Does it have long-lasting adverse effects?
There is nothing 100% safe in medicine. Even when we take something as common as paracetamol, it can carry risks.
The data, for the moment, are comforting. Trials in 43,500 people have not raised any safety concerns, although mild adverse effects have been reported.
It is believed that if there were dangerous and common consequences from this vaccine, they would already be visible.
But keep in mind that Isolated adverse effects can occur when millions of people become immunized.
6. Does it mean that lockdowns will end?
Hopefully yes, but not yet.
If enough people are immune, the virus will stop spreading and we would need no other measures to control it.
The challenge, however, is to navigate from now to that point.
There are still the monumental challenges of making enough vaccines and supplying them to people. All of this is going to take time and until then we need to control the virus.
So testing, confining, respecting social distance and wearing masks will remain in our lives for a while.
7. What happens if the virus mutates?
Viruses mutate all the time, that’s what they do. The question is whether they mutate in a way that changes their behavior.
At the moment there is no indication that it is happening, although it is possible that in the future changes in the virus will make the vaccine less effective.
If that happens, a new vaccine would be needed.
This is not unusual. Every year a new flu vaccine is designed to fight the strains that are circulating.
And the RNA technology in the new vaccine is very easy to modify, so it shouldn’t be a serious problem.
8. What is missing to know about the vaccine?
The ad has given us the headline, but concrete details are still missing.
We do not know if the vaccine will prevent get infected and spread the virus or just keep you from getting sick. We also do not know how much it will protect according to age group.
This will be crucial to understanding how it will be used.
9. What does this mean for other vaccines?
Are good news. It shows that a coronavirus vaccine is possible, something we weren’t sure of a couple of days ago.
Since many vaccines aim to attack the same part of the virus, known as the spike protein, there is hope that they will work as well.
There are around of a dozen vaccines in the final stages of clinical development.
No other vaccine has shown its high effectiveness in such a short time.
We are still waiting for more complete data, but these results are better than what many were hoping for. A good flu shot protects about half of people, so 90% on the first try can be considered a success.
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Digsmak is a news publisher with over 12 years of reporting experiance; and have published in many industry leading publications and news sites.