some information from the media
The two companies said, “This is an important day for humans and science.” At present, the number of confirmed cases of new coronary pneumonia in the United States has exceeded 10 million. Pfizer Chairman and CEO Albert Burla said that such a result undoubtedly allows "we can see the light at the end of the tunnel."
The news immediately detonated the global capital market. But it needs to be pointed out that the results released on Monday are only an early analysis, and people still have a lot of unknowns about this vaccine and its effectiveness. The reporter of "Daily Business News" sorted out 11 things you need to know about Pfizer vaccine:
1. What did the scientists discover?
Pfizer and BioNTech launched a late-stage clinical trial of the new crown vaccine in July. Nearly 44,000 volunteers participated in the trial, vaccinated and placebo respectively, 94 volunteers have been infected with the new crown. Early analysis shows that the vaccine is more than 90% effective. The clinical trial adopts a double-blind design. Only an independent committee knows how many of the 94 infected people were vaccinated and how many were given a placebo.
2. Is this a good result?
Yes. According to the relevant regulations of the U.S. Food and Drug Administration (FDA), the candidate vaccine can be applied for emergency use authorization when the vaccine candidate's effectiveness reaches 50%. The preliminary results of Pfizer vaccine are much higher than this. We can compare the effectiveness of Pfizer vaccine through a set of data: the effectiveness of the influenza vaccine is 40-60%, because influenza viruses mutate every year; the effectiveness of two doses of measles vaccine is 97%.
3. Is Pfizer vaccine safe?
Till now, neither Pfizer nor BioNTech have reported serious safety issues. Before the large-scale trials, the two companies started small-scale clinical trials in May to find warning signs about vaccine safety. They tested four versions, and the last selected version had the least mild and moderate side effects such as fever and fatigue among the subjects.
If Pfizer vaccine obtains FDA emergency use authorization and is distributed to millions of people, the US Centers for Disease Control and FDA will closely follow it to ensure that there is no safety risk. Pfizer will also continue to follow all subjects for two years to observe the durability of the immune response.
4. Who will be vaccinated first?
Pfizer CEO stated that 30-40 million doses of vaccine will be launched by the end of this year, enough to vaccinate 15-20 million people. It has not yet been determined who will be vaccinated first, but health care workers, elderly people, and people with diabetes or obesity who are vulnerable to infection will have priority.
Pfizer and BioNTech stated that its annual production capacity can reach 1.3 billion doses, but it is far from enough to meet global demand. If other vaccines are proven effective, the company can also produce them to help meet demand.
5. When can ordinary people be vaccinated?
Pfizer stated that the company plans to apply for emergency authorization in the third week of November after collecting safety data for two months as required by the FDA. Then, the FDA will consult with an external expert advisory committee to carefully study detailed data such as vaccine safety, effectiveness, and the company's ability to safely produce millions of doses of vaccine.
If everything goes according to plan without any delay, the vaccine can be used by some high-risk groups before the end of the year.
6. Next, what needs to be done for the test?
Pfizer said it will continue the trial until 164 confirmed cases of new crown among the volunteers. Although the initial results are satisfactory, its effectiveness has not been fully proven. The effectiveness of the vaccine can only be fully determined after millions of people have been vaccinated.
7. Are vaccines useful for the elderly?
The results announced by Pfizer on Monday did not explain whether the vaccine can help the elderly stay away from the virus. However, clinical trials conducted by Pfizer and BioNTech have volunteers over 65 years old, so relevant information will eventually be released. Early clinical studies have shown that the coronavirus vaccine produces a weak immune response in the elderly. But considering the excellent preliminary effectiveness data of Pfizer vaccine, the vaccine may also provide strong protection for the elderly.
According to media reports, BioNTech CEO Ugur Sahin said that about half of the volunteers are elderly. Inferring from the current results, the effectiveness of the new crown vaccine for elderly people should be above 80%, but more analysis is needed to determine .
8. Are vaccines useful for children?
Initially, the volunteers recruited by Pfizer and BioNTech for their clinical trials were all aged 18 years and above, and it was not until September that they were expanded to the 16-year-old group. Last month, they began testing the new crown vaccine among teenagers as young as 12 years old.
9. Is the vaccine part of the government's "Action Warp" plan?
US Vice President Pence said on Monday local time that Pfizer’s new crown vaccine research and development benefited from the support of the US government’s "Action Warp" project, but in fact, Pfizer did not receive federal funding. According to Reuters, Pfizer’s partner BioNTech announced in September that the German government allocated US$445 million to BioNTech to help accelerate the development and production of the new crown vaccine.
10. What does this mean for other vaccines under development?
At present, there are more than 10 vaccines in the final stage of trials worldwide. The encouraging results achieved by Pfizer and BioNTech in the trials give experts more hope and will also inspire other vaccine developers.
Pfizer and BioNTech's vaccines cause human cells to produce a viral protein called a spike. Many other vaccines send spike proteins into the body to trigger the immune system to recognize and prevent it. If the spike protein can trigger the immune system to respond to it, then all these vaccines may achieve promising results in the coming months.
11. Can I not wear a mask now?
The COVID-19 virus is still raging, so don’t remove the mask.
Even if the vaccine is authorized for emergency use within a few months, only some people can get it initially. Not only that, there is currently no data to show whether the vaccine can prevent the asymptomatic transmission of the virus, and to what extent the vaccine can prevent the development of severe symptoms.
Most experts said that even if vaccines become widespread, wearing masks and other preventive measures are still necessary unless the public health threat is eliminated.