A coronavirus vaccine may be ready in October, U.S. President Donald Trump said at a White House briefing Monday.
The prospect of a vaccine to shield Americans from coronavirus infection emerged Monday as a point of contention in the White House race as president Donald Trump accused Democrats of “disparaging” for political gain a vaccine he repeatedly has said could be available before the election.
“It’s so dangerous for our country, what they say, but the vaccine will be very safe and very effective,” the president pledged at a White House news conference.
Trump leveled the accusation a day after Sen. Kamala Harris, the Democrats’ vice presidential candidate, said she “would not trust his word” on getting the vaccine. “I would trust the word of public health experts and scientists, but not Donald Trump,” Harris said.
Democratic presidential candidate Joe Biden amplified Harris’ comments Monday after he was asked if he would get a vaccine for COVID-19, the disease caused by the novel coronavirus. Biden said he’d take a vaccine “tomorrow”want to see what the scientists have to say, too.
Biden said Trump has said “so many things that aren’t true, I’m worried if we do have a really good vaccine, people are going to be reluctant to take it. So he’s undermining public confidence.”
Still, the former vice president said, “If I could get a vaccine tomorrow I’d do it, if it would cost me the election I’d do it. We need a vaccine and we need it now.”
Johnson & Johnson said Wednesday it has begun its phase three trial testing its potential coronavirus vaccine.
J&J is the fourth drugmaker backed by the Trump administration’s Covid-19 vaccine program Operation Warp Speed to enter late-stage testing. The others are Moderna, Pfizer and AstraZeneca.
The trial will enroll up to 60,000 adult volunteers across 215 locations in the U.S. and other countries, according to the National Institute of Allergy and Infectious Diseases. Participants will be randomly selected to receive a dose of the potential vaccine or a placebo, according to details of the trial, which will determine whether the vaccine is safe and effective.
“Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified,” institute director Dr. Anthony Fauci said in a statement.
“This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia,” he said. “It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose.”
J&J, parent company of Janssen, has said it is using the same technologies it used to develop its experimental Ebola vaccine. It involves combing genetic material from the coronavirus with a modified adenovirus that is known to cause common colds in humans.
Preclinical studies have shown J&J’s potential Covid-19 vaccine can generate a promising response in nonhuman primates and hamsters.
Paul Stoffels, J&J’s chief scientific officer, told reporters on a conference call Tuesday that early-stage trial data, which will be released “imminently,” shows the immune response in humans was “comparable to animals, which were protected.” He also said the vaccine appeared to be well-tolerated, with symptoms such as fever resolving within 48 hours.
He said it will likely take six weeks to two months to reach 60,000 participants, allowing J&J to recruit a diverse cohort. The trial will include those with and without other ailments associated with an increased risk for progression to severe Covid-19, and will aim to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.
“There are a lot of what we call ‘readiness cohorts,’ where we have predetermined in high risk areas the specific populations we want to target,” he said. “The data teams have been working hard to find out where in the U.S., where in other parts of the world, we can get access to the people and parts of the population at high risk and diverse, which we need to have in the clinical trials.”
The U.S. is increasingly likely to get a vaccine authorized for emergency use before the end of the year, with Pfizer (PFE) and partner BioNTech (BNTX) ready to file by the third week of November.
Pfizer CEO Albert Bourla penned a letter addressing the American people Friday, explaining the vaccine trial process and why and how the company hopes to have initial data by the end of October— a timeline the company has maintained all along— but will wait until November to apply for emergency use.
The U.S. Food and Drug Administration (FDA) recently adopted guidelines to ensure safety through an extended monitoring period of two months, an increase from the previous one month. The move has been lauded by health experts, but has also been a political win for the health agency in thwarting pressure from the White House to have a vaccine by Election Day.
In his letter, Bourla explained there were three areas of focus: safety, efficacy and manufacturing quality data.
“To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas,” Bourla said.
“A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use,” he added.
Top FDA officials also weighed in on the follow-up timeline in the New England Journal of Medicine Friday.
“At stake is public confidence in America’s response to the pandemic, in Covid-19 vaccines, and in vaccines in general, all of which are essential to achieving desired public health outcomes,” the authors wrote. They noted that a two month follow-up period was necessary because of the pandemic, but otherwise a six month follow-up is the norm.
“The FDA generally requires at least 6 months of safety follow-up,” they said, adding, “Given that some vaccines under evaluation for preventing Covid-19 are based on technologies not previously used in licensed vaccines, arguments could be made in favor of longer safety follow-up to support an EUA.”
UK chief scientific advisor, Patrick Vallance, weighs in with his latest thoughts about a vaccine and how the world may look like in the future
He argues that while there are positive developments in the vaccine space, none are likely to eradicate the coronavirus:
The notion of eliminating Covid from anywhere is not right, because it will come back. Clearly as management becomes better, as you get vaccination which would decrease the chance of infection and the severity of disease ... this then starts to look more like annual flu than anything else, and that may be the direction we end up going.
Adding that his best assessment is that it is unlikely the world will end up with a truly sterilising vaccine i.e. one that completely stops the infection altogether, instead the coronavirus will continue to circulate and end up being 'endemic'.
Vallance also made reference to the fact that there had only ever been one human disease that has been 'truly eradicated' thanks to a highly effective vaccine, being smallpox.
On the timing for a vaccine, he doesn't believe that there would be any available for widespread use until at least spring.
The ambitious drive to produce Covid-19 vaccine at warp speed seems to be running up against reality. We all probably need to reset our expectations about how quickly we’re going to be able to be vaccinated.
Pauses in clinical trials to investigate potential safety issues, a slower-than-expected rate of infections among participants in at least one of the trials, and signals that an expert panel advising the Food and Drug Administration may not be comfortable recommending use of vaccines on very limited safety and efficacy data appear to be adding up to a slippage in the estimates of when vaccine will be ready to be deployed.
Asked Wednesday about when he expects the FDA will greenlight use of the first vaccines, Anthony Fauci moved the administration’s stated goalpost.
“Could be January, could be later. We don’t know,” Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an online interview with JAMA editor Howard Bauchner.
On Tuesday, front-runner Pfizer revealed in an earnings call that the first interim analysis in its Phase 3 clinical trial has not yet occurred. That means there hadn’t yet been enough Covid infections among the trial participants to take a first stab at analyzing whether the people randomly assigned to receive vaccine were infected at a lower rate than people who were assigned to get a placebo injection.
It’s possible that the company will cross that threshold sooner rather than later. But Pfizer, which has been one of the most aggressive players in the vaccine race, had earlier predicted it would know by the end of September if its vaccine worked — an estimate that was later pushed back to late October. The company now projects that it could apply to the FDA for an emergency use authorization for the vaccine, which it is developing with BioNTech, in mid-November.
It is important to note that, to date, none of the vaccines being developed for the U.S. market has been proven to be effective in preventing Covid-19 disease. Early stage clinical trials have shown what appear to be promising signals; multiple vaccines have triggered production of important antibodies in people who have been immunized.
But data generated in a few hundred people aren’t enough to determine whether a vaccine will actually fend off illness. That answer comes from large, Phase 3 trials, five of which are now underway in the United States. Their findings will ultimately tell us how soon vaccines may start to be rolled out to the masses.
The administration has been saying for months that vaccine would be ready for deployment before the end of the year. In fact, President Trump had been hinting vaccine could be pushed out before Election Day, which it will not be; at a campaign rally on Wednesday night, he said vaccine would be ready “momentarily.”
Other officials have been bullish in their own right. Just last Friday, Paul Mango, deputy chief of staff for policy for Health and Human Services Secretary Alex Azar, reiterated the administration’s projection that all Americans who want to be vaccinated against Covid-19 will have that opportunity by the early spring.