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Past Vaccine Disasters Show Why Rushing A Coronavirus Vaccine Now Would Be 'colossally Stupid' - CNN
CNN —
Vaccine experts are warning the federal government against rushing out a coronavirus vaccine before testing has shown it�™s both safe and effective. Decades of history show why they�™re right.
Their concern that the FDA may be moving too quickly heightened when FDA Commissioner Dr. Steven Hahn told the Financial Times that his agency could consider an emergency use authorization (EUA) for a Covid-19 vaccine before late stage clinical trials are complete if the data show strong enough evidence it would protect people.
The commissioner has the authority to allow unapproved medical products to be used in an emergency when there are no adequate or approved alternatives. An EUA is not the same as full approval and it can be withdrawn.
That�™s what happened with hydroxychloroquine and chloroquine. The FDA granted an EUA to the drugs �" much praised by President Donald Trump �" on March 28. It subsequently revoked its EUA in June after studies showed they were not effective and could also potentially cause serious heart problems.
For a vaccine to be FDA approved, scientists must gather enough data through clinical trials in large numbers of volunteers to prove it is safe and effective at protecting people against a disease. Once the data is collected, FDA advisers usually spend months considering it.
An EUA is much quicker. Only once before has the FDA given a vaccine this lesser standard approval of an EUA, but it was in an unusual circumstance. Soldiers had sued, claiming a mandatory anthrax vaccine made them sick, and a judge put a hold on the program. The Department of Defense asked for an EUA that then overrode the court ruling in 2005, so it could continue vaccinating military personnel �" this time on a voluntary basis.
Otherwise, vaccines have had to go through the entire clinical trial process and FDA approval process, which can take months or years.
When the vaccine making process has been rushed, there have been bad outcomes.
On April 12, 1955 the government announced the first vaccine to protect kids against polio. Within days, labs had made thousands of lots of the vaccine. Batches made by one company, Cutter Labs, accidentally contained live polio virus and it caused an outbreak.
More than 200,000 children got the polio vaccine, but within days the government had to abandon the program.
�œForty thousand kids got polio. Some had low levels, a couple hundred were left with paralysis, and about 10 died," said Dr. Howard Markel, a pediatrician, distinguished professor, and director of the Center for the History of Medicine at the University of Michigan. The government suspended the vaccination program until it could determine what went wrong.
However, increased oversight failed to discover another problem with the polio vaccine.
From 1955 to 1963, between 10% and 30% of polio vaccines were contaminated with simian virus 40 (SV40).
�œThe way they would grow the virus was on monkey tissues. These rhesus macaques were imported from India, tens of thousands of them," medical anthropologist S. Lochlann Jain said. �œThey were gang caged and in those conditions, the ones that didn�™t die on the journey, many got sick, and the viruses spread quickly," added Jain, who taught a history of vaccines course at Stanford and is working on a publication about the incident. Scientists wrongly thought the formaldehyde they used would kill the virus. �œIt was being transferred to millions of Americans," Jain said.
�œMany believe this issue wasn�™t adequately pursued," Jain said. Some studies showed a possible link between the virus and cancer. The US Centers for Disease Control website, however, said most studies are �œreassuring" and find no link.
No current vaccines contain SV40 virus, the CDC says, and there�™s no evidence the contamination harmed anyone.
In 1976, scientists predicted a pandemic of a new strain of influenza called swine flu. More than 40 years later, some historians call it �œflu epidemic that never was."
�œPresident Ford was basically told by his advisers, that look, we have a pandemic flu coming called swine flu that may be as bad as Spanish flu," said Michael Kinch, a professor of radiation oncology in the school of medicine at Washington University in St. Louis. His latest book, �œBetween Hope and Fear," explores the history of vaccines.
�œFord was being cajoled to put forward a vaccine that was hastily put together. When you have a brand new strain situation like that, they had to do it on the fly," Kinch said.
Ford made the decision to make the immunization compulsory.
The government launched the program in about seven months and 40 million people got vaccinated against swine flu, according to the CDC. That vaccination campaign was later linked to cases of a neurological disorder called Guillain-Barre syndrome, which can develop after an infection or, rarely, after vaccination with a live vaccine.
�œUnfortunately, due to that vaccine, and the fact that it was done so hastily, there were a few hundred cases of Guillain-Barre, although it�™s not definitive that they were linked," Kinch said.
The CDC said the increased risk was about 1 additional case of Gullain-Barre for every 100,000 people who got the swine flu vaccine. Due to this small association, the government stopped the program to investigate.
�œIt was kind of a fiasco," Markel said. �œThe good news is that there never was an epidemic of swine flu. So we were safe, but that shows you what could happen."
It took several incidents for people to start distrusting vaccines. Even after thousands of kids got sick from the first polio vaccine in 1955, when the program restarted, parents made sure their children got vaccinated. They had clear memories of epidemics that paralyzed between 13,000 and 20,000 children every year. Some were so profoundly paralyzed that they could not even breathe easily on their own, and relied on machines called iron lungs to help them breathe.
�œParents were pushing their kids to get to the head of the line to get the polio vaccine, because they had seen epidemics every summer for years, and saw kids in iron lungs and they were terrified," Markel said.
Markel said people�™s attitudes started to change between 1955 and the problematic 1976 swine flu vaccination project.
�œYou�™ve got civil rights, when people see the cops beating the hell out of people on TV. You�™ve got the Vietnam War where people start to get disgusted with the killing. You�™ve got Watergate when the president is literally lying through his teeth," Markel said. �œThat led to a real distrust of authorities and federal government, and it extended to doctors and scientists. And, that�™s only progressed as time has gone along."
Markel said people�™s mistrust of the system makes the idea that the FDA would rush this process before late stage clinical trials are complete �œcolossally stupid."
�œThis is one of the most ridiculous things I�™ve heard this administration say," Markel said. �œAll it takes is one bad side effect to basically botch a vaccine program that we desperately need against this virus. It�™s a prescription for disaster."
FDA Commissioner Hahn said that the vaccine decision will be based on data, not politics, but Kinch shares Markel�™s concern.
�œThis could do substantial damage," Kinch said. Kinch, who is a patient in one of the vaccine trials himself, said the clinical trial process needs to be followed to the end. A too-early EUA for a vaccine could cause a �œnightmare scenario," for a few reasons.
One, the vaccine may not be safe. Two, if it is not safe, people will lose faith in vaccines. Three, if a vaccine doesn�™t offer complete protection, people will have a false sense of security and increase their risk. Four, if a substandard vaccine gets an EUA, a better vaccine may never get approval, because people would be reluctant to enroll in trials and risk getting a placebo instead of a vaccine.
�œPeople are going to die unnecessarily if we take chances with this," Kinch said. �œWe�™ve got to get this right."
Covid-19 Vaccine: Pfizer Applies For Emergency Use Approval From FDA - Vox
Just last week, Pfizer and BioNTech revealed that their experimental Covid-19 vaccine, called BNT162b2, was at least 90 percent effective in an early analysis. On Wednesday, the pharmaceutical and biotech companies reported that their vaccine was even more effective after it cleared more clinical trial benchmarks for safety and efficacy. And on Friday, they said they are requesting an emergency use authorization (EUA) from the Food and Drug Administration.
If granted an EUA, the BNT162b2 vaccine could be administered to certain high-risk groups in the United States — most likely health workers — as soon as mid-December. Pfizer and BioNTech are filing for similar approvals in other countries as well.
"Filing for Emergency Use Authorization in the US is a critical step in making our vaccine candidate available to the global population as quickly as possible," said Ugur Sahin, CEO and cofounder of BioNTech, in a statement.
The companies are confident in their vaccine after showing strong results from their phase 3 clinical trial: Out of 170 Covid-19 cases, eight people that received the vaccine got Covid-19 versus 162 in the placebo group, an efficacy of 95 percent. They also say there are no "serious safety concerns related to the vaccine."
A competitor, the vaccine developer Moderna, also recently reported that its vaccine was 94.5 percent effective in an early analysis.
It's worth pausing to reflect on where we are: At the one-year anniversary of the first detection in China of the SARS-CoV-2 virus, the pathogen that causes Covid-19, there are now two highly effective vaccine candidates developed at a record pace, both using mRNA, a new vaccine technology that has never before been approved for use in humans.
The announcements are a breathtaking feat of science, international collaboration, and public investment. "The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic," said Albert Bourla, Pfizer chair and CEO, in a statement.
But there are concerns as well. Pfizer and BioNTech's announcement of its efficacy results came, for the second time, in a press release instead of a peer-reviewed paper, although the companies revealed far more about the demographics of their clinical trial than in their first report. BNT162b2 also has some of the most stringent cold storage requirements of any vaccine, demanding temperatures of minus 70 degrees Celsius (minus 94 degrees Fahrenheit) or lower, which may make widespread distribution challenging. The vaccine is also administered in two doses spaced several weeks apart. That adds a huge logistical burden to rolling it out.
That the clinical trial racked up so many Covid-19 cases among its volunteers so quickly is also a grim reminder of just how fast the disease is spreading right now.
And it will likely take months before any Covid-19 vaccine gets full FDA approval, which would allow the general public to have access to it. Even then, immunizing millions of people in the US against Covid-19 would be an endeavor unprecedented in its speed and scale. So getting an EUA is just one step toward ending the pandemic.
Pfizer and BioNTech say their Covid-19 vaccine was safe and effective across a diverse pool of volunteers
Pfizer and BioNTech's Covid-19 vaccine data so far is still preliminary, but it likely received validation from its Data Safety Monitoring Board (DSMB). This is an independent group of scientists that serves as an intermediary between the pharmaceutical companies and the clinical trial participants to ensure that there is no meddling in the trial. The DSMB meets with the companies at regular intervals to go over their observations of the trial. The fact that Pfizer and BioNTech were able to make this announcement likely means the committee reported this information to them during an analysis.
"To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine," the companies reported in their press release. In a separate trial of 8,000 participants, Pfizer and BioNTech reported that the only severe side effects they found that occurred in more than 2 percent of volunteers were fatigue, observed in 3.8 percent of participants, and headache, observed in 2 percent. Surprisingly, the companies found that older adults reported fewer and milder side effects.
The trial also recruited a diverse pool of volunteers to see how well the vaccine would work among different populations. About 30 percent of US trial participants came from diverse racial and ethnic backgrounds, and 45 percent were between the ages of 56 and 85. "Efficacy was consistent across age, gender, race and ethnicity demographics," the companies reported.
What emergency use authorization means for a Covid-19 vaccine
During a public health crisis, the FDA can grant an EUA to allow unapproved medical products to treat or prevent serious diseases when there are no adequate alternatives on the market.
The benchmark for an EUA is lower than it is for full approval of licensure. In general, the treatment in question has to have a likely benefit, whereas approval demands evidence of a proven benefit.
However, it's not just about efficacy. A vaccine has the additional hurdle of a much higher bar for safety than conventional drugs. Since a vaccine has to be distributed to millions of people, including those who are healthy and those who have preexisting conditions, the rate of complications has to be extremely low for both full approval and an EUA.
"The thing people need to keep in mind is the safety data. Do we have enough data on safety at this point that we can go forward with the EUA?" said Jose Romero, chair of the Advisory Committee on Immunization Practices (ACIP), an independent group of health experts that advises the Centers for Disease Control and Prevention on vaccines. "I think the FDA, ACIP, and all of the pharmaceutical companies have said over and over again that safety is paramount as they move forward with full licensure or an EUA for vaccines."
The burden of approving a Covid-19 vaccine isn't just on the companies. The FDA also has to be transparent about how it is making decisions. This is especially important given that public mistrust of a vaccine could be a major hurdle in the effort to contain the Covid-19 pandemic in the US.
Some experts are worried that the FDA damaged its credibility this year with its decisions to grant EUAs to treatments like hydroxychloroquine and convalescent plasma based on weak data, which may have been driven by political pressure from the White House. Some researchers have also criticized the FDA's full approval of the antiviral drug remdesivir. These decisions have sown doubt about the FDA's decision-making, and the agency will have to go out of its way to rebuild fragile trust with the public to roll out a vaccine.
How do we decide who gets a Covid-19 vaccine first?
Once an EUA is granted, the Covid-19 vaccine can start to be administered to people outside of the clinical trial. Health workers — doctors, nurses, first responders, medical cleaning staff — are the top priority. "They're certainly high on the list," Romero said.
Then the vaccine would be targeted at people who are likely to suffer severe complications from Covid-19, such as people over the age of 65 with other underlying health conditions.
Pfizer and BioNTech said they only expect to have 50 million vaccine doses around the world by the end of the year. And remember, this is a two-dose vaccine, so 50 million doses will only protect 25 million people. That means there won't be enough to go around, even for people at high risk. The companies do expect to have 1.3 billion doses ready in 2021.
ACIP is now putting together its recommendations for how to prioritize people for Covid-19 vaccination. But Romero explained they will also have to consider that there will likely be multiple vaccines on the market shortly. A dozen Covid-19 vaccine candidates are already in phase 3 trials, each with their own unique traits and caveats.
"It's a little silly to think that all vaccines are going to be ranked the same, because they'll have different characteristics," Romero said. "Some vaccines may be better in younger populations; some may be better in older populations."
The advisory committee will also have to weigh practicality, including the minus 70 degree Celsius storage requirements of the Pfizer-BioNTech vaccine. "Those are going to be very important and impact significantly the logistics of getting these vaccines out and into the arms of recipients," Romero said. "It's hard to imagine how you're going to set up a system to deliver a vaccine that requires storage at minus 70 [Celsius] into the widespread community."
It's likely, then, that the BNT162b2 vaccine will be reserved at the outset for health workers who are already working in and around facilities that have the ultra-cold storage systems for this vaccine, or those who are near facilities that are equipped to distribute it. For those in far-flung regions or people who don't have sophisticated $10,000 freezers nearby, a vaccine with easier storage requirements may be recommended. Moderna's vaccine, for example, only needs long-term storage at minus 20 degrees Celsius (minus 4 degrees Fahrenheit) and is stable for 30 days between 2°C and 8°C (36°F to 46°F).
Pfizer and BioNTech say they do have a solution for getting their vaccine to places without ultra-cold freezers. "The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C," according to their press release. "They can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer's broad distribution network."
However, even with a green light from the FDA and assembly lines cranking out millions of vaccine vials, developers like Pfizer and BioNTech will still have to keep an eye on the people who received the vaccine to ensure there aren't any super-rare complications that could arise. "I think it's important for the public to understand that the process doesn't end with approval," Romero said.
For their part, Pfizer and BioNTech said they will continue monitoring their clinical trial participants for two years.
As these vaccines gradually roll out, people will still have to keep up measures to limit the spread of the virus: wearing masks, maintaining social distance, keeping up good hygiene. Until there is widespread vaccination, Covid-19 will remain dangerous and deadly, and the steps taken to mitigate it now will ensure a smoother and more effective campaign to halt the pandemic.
FDA COVID Vaccine Chief: We'll Be Independent, Transparent, Trustworthy - USA TODAY
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