Pfizer Offers New Hope

New data from clinical trials is looking very promising.

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Throughout the long months of the coronavirus pandemic, there has always been the hope that a vaccine for Covid-19 would be developed. Some of the world’s best researchers have been hard at work and there  are currently 52 vaccines in human trials – 11 in late stage trials –, according to the New York Times, while more are still in animal testing.

This has been an exciting light-speed race to see which of these vaccines would prove safe and effective and ready to go into production. So, while good news has been progressing at a fast pace, a press release  announcement on November 9, 2020 from Pfizer, located in New York, that the vaccine they developed with German drug maker BioNTech has proven 90 percent effective in preventing the disease in clinical trial participants,  is cause for celebration.

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO in the press release.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” he said. “With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

If these results hold up, the double-dose mRNA-based vaccine will be as effective as those used against diseases like measles. The company also said that there have been no reported serious safety concerns and that the study will continue to collect data. While the results are not yet peer reviewed, when all the data is collected after the trial participants receive the second dose, later in November, Pfizer will request an Emergency Use Authorization from the FDA.

The company told the New York Times that it will manufacture enough doses to immunize 15 to 20 million people by the end of 2020. “This is a historical moment,” Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer told NYT. “This was a devastating situation, a pandemic, and we have embarked on a path and a goal that nobody ever has achieved — to come up with a vaccine within a year.”

The work on the vaccine began in Mainz, Germany in late January 2020 after Ugur Sahin, the CEO and cofounder of BioNTech read about the virus and he said it filled him with dread. He assembled a 40-person team to work on the project they aptly named Project Lightspeed.

BioNTech and Pfizer worked together to develop a flu vaccine in 2018 and the companies agreed to partner on the coronavirus vaccine in March. They initially found two vaccine candidates that produced a strong immune response including antibodies against the virus. They chose the one that had the least side effects and began trials with 30,000 volunteer participants in the US, Germany, Argentina, and Brazil.

The trials were expanded to 44,000 people in September. But even before that, the US government secured an advance purchase agreement with the partners on July 22.

The US government already promised $1.95 billion to deliver 100 million doses to the federal government which will be given to American’s for free but it is important to note that no federal money was given to the company to help pay for research and development, according to the NYT, and they were not influenced by politics; only science.

Other vaccine trials are also progressing and there may be more announcements in the coming weeks from other companies. It will still take time to produce enough vaccines to inoculate people globally but there is now hope in the fight against Covid-19 that there will be a vaccine available in record time.

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