Pfizer, one of the pioneers in the search for a COVID-19 vaccine, said her vaccine candidate looks and that the company hopes to learn next month about how it protects others from coronavirus.
Pfizer CEO Albert Bourla said Tuesday that he deliberately shows more data on the COVID-19 candidate vaccine than on any other vaccine in progress because the procedure must be open and transparent.
“Transparency is imperative, especially given this and the politicization of the vaccine,” he said in an interview with journalists.
The company had announced Saturday that it would expand its trial from 30,000 to 44,000 more people to accompany adolescents over 16 to 18, as well as others with diseases such as HIV and hepatitis A, B or C. On Tuesday, Bourla said the expansion took a position because the vaccine seemed incredibly safe, and the trial could expand without delaying the final touch schedule.
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In the knowledge published Tuesday, the company showed that players, younger or older, complained of minor side effects, such as headaches and arm pain. Knowledge included about 6,000 people; some won the active vaccine and others won the placebo. The company, which is launching its vaccine, called BNT162, in collaboration with German vaccine developer BioNTech, does not know which player received which player received which vaccine.
An independent knowledge safety commission knows who won the active vaccine and verifies that there are no fitness issues, Pfizer executives said.
Serious physical disorders were most likely in the trial, but the protection organization “concluded that none were vaccine-related,” said Kathrin Jansen, Pfizer’s senior vice president and head of vaccine studies and development.
Higher numbers also allow the company to take a closer look at subgroups of participants, such as those with underlying fitness disorders such as HIV, and those who had the virus when they won the vaccine, he said.
A final report on the protection and efficacy of the vaccine will be in a position to be reviewed by regulators next month.
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The vaccine will have to be at least 50% effective – protective on average at least to other people who take it – in order for it to download federal approval and be delivered to the public. Pfizer recently manufactures BNT162 in 3 plants in the United States. – Kalamazoo, Michigan, St. Louis, Missouri and Andover, Massachusetts, as well as in Germany and Belgium.
It is not yet known how long the vaccine will be protected. The company is preparing for 3 possibilities: that other people will want an annual vaccine like the flu, that they will want a vaccine every few years, as for tetanus, or that it will be one and ready, like the polio vaccine, said Dr. Mikael Dolsten, clinical director of the company.
“We, this vaccine has the possibility of providing moderate and effective protection, but we want to monitor it,” Dolsten said. “It is also moderate to assume that we may want a seasoning in the future, as it is a genuine pandemic. and there will be many viruses circulating even after the global [vaccination] campaigns. “
Jansen said that while Pfizer is still engaged and “very satisfied with his existing vaccine candidate,” the company is already operating in a generation of times.
Pfizer hopes to make two significant innovations with the next generation, he said: get rid of the desire to keep the vaccine frozen and modify the generation so that a singles dose is desired, rather than two.
BNT162 uses a generation called messenger RNA, which trains a person’s cells to produce a protein on the surface of the coVID-19 coronavirus. Once the immune formula learns to recognize this protein, it will attack when you see it again in the genuine virus. .
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In a next-generation vaccine, Jansen said, she could be a messenger RNA that can also simply grow. “There would probably be an opportunity for you with such an approach, you may only want an injection,” which would provide ” bait and stimulation. “effect. “
The vaccine will have to be kept frozen at less than 80 degrees lately, the temperature of the ice dry. Pfizer does this by shipping the BNT162 in portable refrigerators that maintain ultra-cold temperatures. The refrigerator can be fed dry ice to keep the vaccine frozen for longer. 15 days, then it can be refrigerated for up to five more days before being diluted and injected, said Angela Hwang, president of Pfizer Biopharmaceuticals.
Because the company expects a strong call for the vaccine and because its existing delivery network is effective, Hwang said it expects the vaccine to suffer heat damage. “No dose will stay for long,” he said.
But a second-generation vaccine that requires bloodless situations would be an improvement, Dolsten said.
Bourla, speaking at the end of a two-day investor conference, lamented the politicization of the COVID-19 vaccine and drug development.
But he said he believes the pharmaceutical industry “is up to the task” of the pandemic and expects it to bring to life the public image of the industry.
“I don’t need to claim a victory, just because we’re passing by to bring a vaccine or a remedy that works, we’re moving on to get back to where we deserve to be, but I think it’s going to be a very smart step. “said. ” Then we have to keep doing the right thing. “
He had a definitive idea at the end of the period: “Science will win,” he said.