It takes many people to develop a COVID-1
Pfizer, one of the frontrunners in the search for a COVID-19 vaccine, said its candidate vaccine looks safe and the company expects to have data next month on how well it protects people against coronavirus.
Pfizer CEO Albert Bourla said on Tuesday that he deliberately reveals more information about the COVID-19 candidate vaccine than he would about any other vaccine under development because he wants the process to be open and transparent.
“Transparency is a must, especially given this situation and the politicization of the vaccine,” he said in a question and answer session with reporters.
The company had said Saturday it was expanding its trial from 30,000 to 44,000 people to include teens ages 16-18 as well as people with diseases such as HIV and hepatitis A, B or C. On Tuesday, Bourla said the expansion took place because the vaccine appeared to be extremely safe, and the experiment could be extended without delaying the timeline for completion.
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In data released Tuesday, the company showed that participants – both younger people and the elderly – only complained of minor side effects, such as headaches and sore arms. The data included about 6,000 people; some who received the active vaccine and others placebo. The company that develops its vaccine, called BNT162, in collaboration with the German vaccine developer BioNTech, does not know which participant got which.
An independent data security commission knows who has received the active vaccine and has checked regularly to make sure there are no health issues, Pfizer executives said.
There have probably been some serious health issues during the trial, but the safety panel has “concluded that no one is vaccine-related,” said Kathrin Jansen, Pfizer’s senior vice president and head of vaccine research and development.
The larger numbers should also allow the company to take a closer look at subgroups of participants, such as those with underlying health conditions such as HIV, and those who had the virus when they received the vaccine, she said.
A final report on the safety and efficacy of the vaccine should be ready for review next month.
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The vaccine must be at least 50% effective – protect on average at least half of the people who take it – in order for it to gain federal approval and be given to the public. Pfizer currently manufactures BNT162 in three factories in the United States – in Kalamazoo, Michigan, St. Louis, Missouri and Andover, Massachusetts – as well as in Germany and Belgium.
It is not yet clear how long the vaccine protection will last. The company is preparing for three options: that people need an annual shot as with the flu, that they need a vaccine every few years, as with tetanus, or that it will be one-and-done, like the polio vaccine, said Dr. . Mikael Dolsten, the company’s scientific director.
“We believe that this vaccine has the potential to provide reasonable and good protection, but we need to monitor [it]”Said Dolsten.” It is also reasonable to assume that we may need a boost in the future because this is a real pandemic and there will be a lot of viruses circulating even after global [vaccination] campaigns. “
Jansen said that although Pfizer is still committed to and “very pleased with its current vaccine candidate,” the company is already working on another generation.
Pfizer hopes to make two significant improvements with the next generation, she said: eliminating the need to keep the vaccine frozen and changing technology so that only one dose is needed instead of two.
BNT162 uses technology called messenger RNA, which trains a person’s cells to make a protein on the surface of the coronavirus that causes COVID-19. Once the immune system learns to recognize this protein, it will attack when it sees it again on the current virus.
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In a next-generation vaccine, Jansen said, she could imagine a messenger RNA that could amplify itself. “There may be a possibility that with such an approach you would be able to need only a single shot,” which would provide both the “priming and boosting effect.”
The vaccine should currently be kept frozen at minus 80 degrees, the temperature of dry ice. Pfizer does the work by sending BNT162 in coolers that maintain the ultra cold temperature. The refrigerator can be fed dry ice to keep the vaccine frozen for 15 days, after which it can be refrigerated for up to five more days before being diluted and injected, said Angela Hwang, president of Pfizer Biopharmaceuticals Group.
Because the company expects high demand for the vaccine, and because its existing shipping network is efficient, Hwang said she does not expect the vaccine to suffer heat damage. “No dose will last very long,” she said.
But a second-generation vaccine that did not require such cold conditions would be an improvement, Dolsten said.
Speaking at the end of a two-day conference for investors, Bourla lamented the politicization of COVID-19 vaccine and drug development.
But he said he believes the pharmaceutical industry is “rising to the occasion” of the pandemic, and hopes it will eventually strengthen the industry’s public image.
“I do not want to declare any victory just because we need to bring a vaccine or a treatment that works that we get back to where we deserve to be, but I think that will be a very good step.” he said. “Then we have to keep doing the right thing.”
He had a concluding thought as he concluded questions and answers: “Science wins,” he said.
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