COLUMBUS, Ohio — A COVID-19 vaccine from Pfizer progressing at historic pace could soon call for a monumental decision from the federal government for an emergency use authorization.
According to Ohio experts involved in the Pfizer vaccine trial, the current timeline would set up a potential Food and Drug Administration authorization in December, at which point 50 million Americans could get the Pfizer vaccine.
In Ohio, labs are working nearly around the clock to enroll participants in vaccine trials and track their progress. The state is strongly represented in the Pfizer vaccine trial, with at least six sites participating. Ohioans have stepped up to participate, wanting to be a part of the historic effort, or hoping to get the protection the vaccine may offer.
The Pfizer trial involved 44,000 participants, half receiving the vaccine and half a placebo. In the current phase of the trial, phase III, Pfizer is studying efficacy and safety. The pharmaceutical company, in partnership with the German company BioNTech, is tracking the difference in outcomes between the placebo group, which will record infections, and the vaccinated group, which will not if the vaccine is effective.
To speed up the vaccine trial, Pfizer targeted parts of the country where there was relatively high occurrence of COVID-19 in the general population. The company can more expediently study the difference between the placebo group and the vaccinated group if the placebo group contracts the virus at a fast rate.
Pfizer made site selections based upon the reputation of labs in those areas with sufficient rates of spread, and their capacity to move quickly in this unprecedented vaccine race.
In Ohio, labs were selected in Dayton and Cincinnati as Southwest, Ohio has recorded some of the highest rates of spread in the state. Labs in Cleveland also enrolled participants.
Sterling Research Group in Cincinnati has a 21-year history of conducting vaccine trials, including a number with Pfizer, said President Donna Percy. The dedicated research center’s proven track record helped it get selected to be a part of the pharmaceutical giant’s COVID-19 effort, she said.
This vaccine trial is unlike any they have ever done in that the participating labs are tasked with working on multiple phases of the vaccine simultaneously while uploading results in very real time, which is all unprecedented for the clinical trial industry, Percy said.
“This overlapping of phases is a new thing. The jury is still out as to whether it's the right process or not, but these are unprecedented times and we're faced with a pandemic,” said Dr. Bain Butcher, Sterling’s principal investigator for the trial. “We’re speeding up from a 10-year timeline to a one-year timeline. If the data is looking good, and if the safety profile is good, then they can move forward.”
Conflicting predictions of the vaccine timeline and the politicization of the vaccine development have distracted the public from the science, which is in fairness fluid and in some respects hard to parse, even to the experts who have studied vaccines for decades.
President Donald Trump had high hopes for a vaccine by the election. Meanwhile, Democratic nominee Joe Biden, and, more staunchly, vice-presidential nominee Kamala Harris have cast doubt about the safety of any vaccine that comes from the Trump administration.
Chair of the department of medicine at Case Western University and University Hospitals, Dr. Robert Salata, said the rapid pace at which the Pfizer vaccine and the other leading candidates are moving represents a fastforwarding of the process but not skipped steps. Salata was chief of the division of infectious diseases for 19 years.
“Pfizer is a bit ahead of the pack in my view because they have such an enormous and successful infrastructure for manufacturing vaccines,” he said. “I don't like the term Operation Warp Speed because it suggests you are possibly cutting corners. The scrutiny with which Pfizer has conducted this study has been incredible.”
The federal government has purchased 100 million doses of the Pfizer vaccine to be delivered by the end of December, to the tune of nearly $2 billion. Pfizer’s vaccine is a two-dose regiment, meaning those 100 million doses could vaccinate 50 million Americans.
The key when it comes to the timing of the decision if the safety and efficacy look good revolves around a proposed two-month waiting period for additional safety analysis.
Under new revised rules, the FDA needs safety data on at least half of vaccine manufacturers' clinical trial subjects for two months after their completion of enrollment in the trial, which for two-dose trials means two months after participants receive their second dose.
Trump opposed the waiting period. “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” he tweeted Tuesday.
In a video message Wednesday, Trump said no president has ever “pushed” the FDA like he has to expedite approvals. “We’re going to have a great vaccine very, very shortly. I think we should have it before the election, but frankly the politics gets involved and that’s OK. They want to play their games. It’s going to be right after the election,” he said.
Salata said Pfizer is still on pace to deliver doses in December as it was contracted to do by the government.
“They are going to wait two months, so that still puts them on track because that will happen in let's say, mid-October so then you wait until mid-December,” he said.
Those 50 million doses could be administered in short order in December and January, Salata said.
Evaluating the federal government’s record so far on the vaccine, Butcher spoke positively of the decision to pour federal dollars into the resource intensive development process, but said of the president and his aides that “there should be much more focus in a unified way on keeping the spotlight on the science of the disease, the science of the pandemic, the science of the vaccine development, and the necessary public health measures that the public needs to be taking, rather than emphasizing the magic bullet story of a vaccine.”
Both the Pfizer vaccine and the Moderna vaccine use new mRNA technology, which is why they are first. It is an easier type of vaccine to develop quickly. But the first vaccine out the gate may not be the best.
“Some types of vaccine are just easier to manufacture than others,” Butcher said. “The ones that require some sort of viral cultures are the hardest to manufacture, but historically help create the most robust immunity.”
Johnson & Johnson’s adenovirus vaccine, for example, would simplify some of the vaccine administration challenges, Salata said. The company is testing single-dose regiments that would eliminate the need for two trips to a site three weeks apart. And the vaccine only requires refrigeration, not the deep freeze that the Pfizer vaccine requires. With limited availability of ultra-low temperature freezers, some sites will not be able to administer the Pfizer vaccine.
Sterling plans to participate in the Novavax trial in a few weeks now that Pfizer is finished enrolling new participants, 400 of whom were enrolled by Sterling. Doing two large vaccine studies at a time would not be feasible with their manpower, especially during a pandemic when it takes a bit longer to administer shots due to the need to spread people out and sanitize between administrations.
Percy said they have added staff to meet the demands of the trial and everyone is working long hours.
As far as side effects with the Pfizer trial, Percy said they been just what you would expect from vaccine, nothing out of the ordinary. She and Butcher would be comfortable getting the shot themselves today, they said.
It will take time to study which vaccine or type of vaccine offers the strongest antibody responses. But experts will not need an answer to the question of which vaccine is best in terms of efficacy before they can start administering one that works well enough to save lives.
Butcher explained that it may well be the case that Americans get the mRNA vaccine in the short-term, and then a year or two later get a different type of vaccine for long-term protection.
Critics of the president’s ambitious predictions for the vaccine have noted the daylight between Trump’s comments and those of Centers for Disease Control and Prevention Director Robert Redfield, who has said widespread availability of the vaccine will not come until the second quarter of 2021.
Under the CDC’s plan, the first doses of the vaccine will go to front line health care workers, followed by first responders, some essential workers, and people at highest risk of morbidity and severe illness – the elderly and those with certain health conditions.
If emergency use authorizations are granted sometime after the election but before the inauguration, the quantity of doses available will not be enough to immediately end the pandemic in the U.S.
Salata said it could take 40 percent of the population immune, but more likely 60 or 70 percent, to really make a really meaningful dent in the virus’s ability to spread.
But the vaccination of the priority groups could shift us into a new phase of the pandemic, and could offer enormous relief for the country, greatly reducing the impact of the virus both on people's lives and on the economy. Morbidity rates would tumble with those first populations vaccinated, and the risks to environments, like nursing homes and prisons, where the virus has spread like wildfire would be dramatically lessened, altering the calculus for governors facing decisions about restrictions on economic sectors.
Adm. Brett Giroir, who is assistant secretary of the Department of Health and Human Services and a White House Coronavirus Task Force member, has said if in November or December the country can get 5 or 10 percent of the population vaccinated, with strategic targeting of the available doses, 80 or 90 percent of the benefit can be achieved.
Butcher explained there will come a time when the pool of people with antibodies – those who have been vaccinated and those who have recovered from the virus – will become large enough to make an impact. It remains an open question how much natural immunity comes from contracting COVID-19, as well as how long that immunity lasts.
“And then you've got everyone else, hopefully, being conscientious about all of the mitigation factors with mask-wearing and social distancing. And slowly, but surely, you should be able to kind of turn the corner,” Butcher said.
In Ohio, it could be the difference that allows urban schools to have an in-person spring semester, or for restaurants to survive the winter, or for grandparents to feel comfortable hugging their grandkids again.
As wonderful as that all sounds, it should not be the focus right now, Butcher said. Thinking of the vaccine as an instant fix that will bring us to the other side of the pandemic is misguided, he said, if it distracts from the measures we can take today to save lives, like social distancing and wearing masks.
“There could be all kinds of stumbling blocks along the way in the development of a vaccine,” he said. “These are novel vaccine technologies. And it's a novel virus.”