this ambitious quest to produce a Covid-19 vaccine with a strain rate seems to contradict reality. We probably all need to reset our expectations about how quickly we can be vaccinated.
Pauses clinical trials to investigate potential safety issues, a slower-than-expected rate of infection among participants in at least one trial, and signals that an expert group advising the Food and Drug Administration may not be comfortable with recommended use of vaccines very limited safety and efficacy data appear to be added to the gap in assessments when the vaccine will be ready for administration.
Asked on Wednesday when he expects the FDA to give the green light to the use of the first vaccines, Anthony Fauci moved the target stated by the administration.
“It could be January, it could be later. We don̵
On Tuesday, the leading Pfizer revealed in a call for profit that the first intermediate analysis in its Phase 3 clinical trial had not yet taken place. This means that there have not yet been enough Covid infections among study participants to take the first step in analyzing whether people randomly assigned to receive the vaccine were infected at a lower rate than people who were vaccinated. were assigned to receive a placebo injection.
It is possible that the company will cross this threshold sooner rather than later. But Pfizer, one of the most aggressive players in the vaccine race, had previously predicted it would know by the end of September if its vaccine was working, an assessment that was later postponed to late October. The company now predicts it could apply to the FDA for permission to use the vaccine, which it is developing with BioNTech, in mid-November.
It is important to note that to date, none of the vaccines developed for the US market have been shown to be effective in preventing Covid-19 disease. The early stages of clinical trials show that they look promising; many vaccines have caused the production of important antibodies in immunized people.
But data from several hundred people is not enough to determine if the vaccine will actually fend off the disease. This answer comes from major Phase 3 trials, five of which are currently underway in the United States. Their findings will eventually tell us how soon vaccines can begin to spread to the masses.
The administration has been saying for months that the vaccine will be ready for introduction before the end of the year. In fact, President Trump has hinted that the vaccine could be pushed out before election day, which it will not be; during an election rally Wednesday night, he said the vaccine would be ready “in a moment.”
Other officials were bullies in their own right. Just last Friday, Paul Mango, deputy chief of staff for health and social services Alex Hazard, reiterated the administration’s prediction that all Americans who want to be vaccinated against Covid-19 will have this opportunity until early spring.
“We believe that before the end of this year we will be able to vaccinate our most vulnerable citizens,” Mango told reporters in an update on Operation Warp Speed, the government’s efforts to speed up vaccines, drugs and Covid-19 diagnostics.
“By the end of January, we believe we will be able to vaccinate all older people. “Until March and April, we believe we can vaccinate any American who wants to be vaccinated,” Mango said.
In fact, this schedule has always been ambitious – probably too much. While Warp Speed and vaccine manufacturers and others involved in the effort have moved heaven and earth to accelerate vaccine production, end-of-day vaccine development, testing, and production takes time. Vaccines are difficult to produce and there are always bumps along the way.
“While it’s unfortunate, I don’t find it surprising that the schedule is moving backwards,” said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota. “Such clinical trials usually have unexpected events that delay the scheduled time. It’s just not unexpected. “
As for the idea that all Americans will have a chance to be vaccinated by early spring, Osterholm suggests that this will take longer.
“For many of us, we never thought it was feasible,” he said. “I congratulate Operation Warp Speed on what it has accomplished in the time it has, but vaccinating the US population until March has never been a realistic goal in my mind.”
Two of the vaccines, supported by Operation Warp Speed, saw a phase 3 pause to investigate unexpected diseases among a small number of study participants.
AstraZeneca, which predicted in June that it could start delivering up to 2 billion doses of vaccine in September, instead saw that its Phase 3 trials in multiple countries were delayed when the participant had neurological symptoms, which President Pascal Sorio said that correspond to transverse myelitis a serious inflammatory disorder. While regulators in the UK, India and South Africa quickly cleared Phase 3 trials to resume volunteer enrollment, the US study was paused for five weeks.
Johnson & Johnson, the only maker of major vaccine manufacturers testing the Covid single-dose vaccine, also saw that the Phase 3 trial was suspended for two weeks after a 20-year-old male volunteer suffered a stroke, the Washington Post reported.
Following an investigation, the FDA allowed J&J to resume the process.
Another manufacturer, Novavax, has moved the start date for its trial phase in the US to the end of November; it was said earlier that the process would begin this month.
Anna Durbin, a vaccine researcher at the Johns Hopkins School of Public Health, said society needs to understand that Covid vaccines may be a little further away than people were forced to believe.
“We can see efficacy in one or more trials by the end of 2020, but that doesn’t mean we will have a vaccine available by the end of 2020,” she said.
“I think what people can perceive from this is that the process is not in a hurry.” That’s a good thing, ‘said Durbin. “And I certainly think the other message that needs to be heard loud and clear is that even when [emergency use authorization] we will not have enough vaccine for everyone [immediately]. “