Pfizer and BioNTech announced vaccine candidate against covid-19 achieved success in first interim analysis from Phase 3 study

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Pfizer’s Early Data Shows Vaccine Is More Than 90% Effective

Pfizer and BioNTech announced on 09 October their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2, that has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted in November 8. 2020.  

Pfizer, which developed the vaccine with the German drugmaker BioNTech, released only seldom details so far from its clinical trials, based on the first formal review of the data by an outside panel of experts.

However, the company said: the analysis found that their vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. If these results hold up, that extent of protection would put this new vaccine on par with well-known, highly effective childhood-vaccines, like measles, which is 93 % effective, according to the Centers for Disease Control and Prevention. The Pfizer results far exceed the US Food and Drug Administration’s criteria for approving a Covid-19 vaccine, which mandates a vaccine efficacy of at least 50 % in placebo-controlled trials. No vaccine has been developed, yet that would provide 100% protection efficacy, according to the World Health Organization.

As for safety: During the tests no serious safety concerns have been observed, in relation with the use of BNT162b2 vaccine, the company communicated.

So, Pfizer plans to ask the Food and Drug Administration for emergency authorization of the two-dose vaccine later this November, after it has collected the recommended two months of safety data. Should this procedure be successful, by the end of 2020, it will have manufactured enough doses of the new vaccine to immunize 15 to 20 million people. Dr. Kathrin Jansen, the senior vice president and head of vaccine development at Pfizer, said „This was a devastating situation, a pandemic, and we have embarked on a path and a goal that nobody has ever achieved — to develope and get a vaccine approved within a year”.

It is indeed, a record-breaking time frame for a process that normally takes about a decade for an effective and safe vaccine. The fastest-ever vaccine development, mumps, took more than four years and was licensed in 1967.

The question that remains unanswered: At present, no one knows how long the vaccine’s protection might last. Still, the development makes Pfizer the first company to announce positive results from a late-stage vaccine trial, vaulting it to the front of a global race that began in January and has unfolded at record-breaking speed.

The short story of BNT162b2 a new type of vaccine: BioNTech used a technology that had never been approved for use in people. They take genetic material called messenger RNA and inject it into muscle cells, which treat it like instructions for building a protein — a protein found on the surface of the coronavirus. The proteins then stimulate the immune system and are believed to result in long-lasting protection against the virus. Other companies, including Moderna, are also using messenger RNA technology.  BioNTech quickly identified 20 vaccine candidates, and began testing them on rodents. But the company lacked the experience and resources to rapidly conduct a major clinical trial. So BioNTech contacted Pfizer. The two companies had been working to develop a flu vaccine since 2018, and within a day of Mr. Sahin founder and president of BioNTech contacted Dr. Jansen at Pfizer, and the two companies agreed to partner on the development of coronavirus vaccine. In March this year, the companies announced their partnership. After early human trials, they determined that two vaccine candidates produced a robust immune response, including antibodies against the virus and powerful immune cells known as T cells. They chose the one with fewer side effects to start a trial with more than 30,000 volunteers in the U.S., Argentina, Brazil and Germany. In September the company expanded the trial to 44,000 participants.

We don’t know if the vaccine contains cyclodextrin. Anyhow, this breaking news should be interesting for the readers of the Cyclodextrin News blog.


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