09.11.2020
08:08
In the first analyzes of the phase of 3 studies, the American laboratory and the BioNTech firm indicated that this level of protection was reached 28 days after the first dose and seven days after the second application.
November 9, 2020 Share on FacebookShare Share on TwitterTweet Share on WhatsAppShare
(Reuters)
Pharmaceutical Pfizer said Monday that its vaccine against covid-19 is ” 90% effective ,” according to the first interim analysis of its phase 3 trial, the last stage before formally requesting its approval.
This protective efficacy against the SARS-CoV-2 virus was achieved seven days after the second dose of vaccine and 28 days after the first , the US pharmaceutical company indicated in a joint statement with the German firm BioNTech. Due to the recent start of studies, it is not possible to know how long the immunity lasts.
The figure is notoriously high, taking into account that some specialists had announced that a formula that reaches 60% immunization would already be a positive result to face the pandemic.
So far, the study has detected 94 infections among patients , the vast majority of which correspond to half of the volunteers who received a placebo and not the actual doses.
The investigation planned to cover 44,000 people and will continue until 164 infections are reached, a proportion that the FDA has agreed is enough to know how well the vaccine is working. The agency has made it clear that any vaccine must be at least 50% effective.
(Reuters)
The report, the first formal review of the provisional data, but not published in the specialized journals, added that no worrisome indicators have been detected about the formula’s safety , beyond some side effects such as fatigue and fever.
The laboratory plans to request an emergency authorization from the Food and Drug Administration (FDA) this month , after two months of data collection, a minimum period recommended by the authorities. Based on projections, both companies said they expect to supply 50 million doses worldwide in 2020 and up to 1.3 billion in 2021.
“We are an important step closer to providing people around the world with much-needed breakthrough to help end this global health crisis. We are reaching this critical milestone in our vaccine development program at a time when the the world needs it the most, ”said Albert Bourla, CEO of Pfizer.
“If that number (90%) really holds up, it’s huge. It is much better than I expected and it will make a big difference, “said Ashish Jha, dean of the School of Public Health at Brown University, to the Statnews portal. However, he cautioned that it is always difficult to evaluate the science through a press release and that researchers will need to see the full results.
For his part, Donald Trump celebrated on Twitter the announcement and the reaction in the stock markets, which rose sharply after the report. “The markets go up big, the vaccine arrives soon, it reports 90% of effectiveness. Great news! ”He wrote. According to the US Department of Health, Pfizer promised that the first 100 million doses produced in the US belong to the government, which supported with USD 1.95 billion for their development.
The vaccine is based on a technology that has not yet been applied in humans: it is messenger RNA, which carries DNA instructions for the cells of the human body to generate certain protective proteins.
The two vaccines hoping to get the green light from the FDA are Pfizer and Moderna. The two US companies plan to apply for an authorization in the second half of November. The FDA did not say when it would comment, but it is expected to do so in late December.
(With information from AFP)
