Federal and state public health officials are gearing up for a massive vaccine campaign against COVID-19.
In Oregon, the planning started in April, just over a month after the first cases emerged in the state. The Oregon Health Authority now has a vaccine planning unit with about 40 people, and it is establishing an advisory group that will include members of communities disproportionately affected by COVID-19 to help guide the vaccination drive.
Oregon health officials say they’ll be ready when the time comes.
That time could be soon.
Dr. Anthony Fauci, director of the federal National Institute of Allergy and Infectious Diseases, said recently that vaccine experts may know by December whether any of the candidates now in an advanced-phase clinical trials are safe and effective though this week he said results might not come in until January or later. Approval by the Food and Drug Administration, which regulates the drug industry, would follow soon after.
At a forum this week, officials leading the administration’s vaccine operation -- Operation Warp Speed -- predicted during an online forum hosted by the Heritage Foundation that hundreds of millions of doses of a COVID-19 vaccine will be available in the United States early next year.
Even if that timeline holds, many questions remain. Chief among them: How many people will want to be vaccinated, how effective will a vaccine be and now long will immunity last?
FDA officials have said that if a vaccine is shown to be safe and is at least 50% effective, it would likely be approved for use.
A 50% efficacy rate means that half of those who receive it would be immune. A vaccine with a 50% efficacy rate could also prevent severe complications and death in some who got sick -- just as the flu vaccine can curb serious illness and fatalities.
Dr. Paul Cieslak, head of the Oregon Health Authority’s immunization program, said that while 50% seems low, it’s a good starting point.
“The real benchmark is, are you better off with the vaccine than without it,” Cieslak told The Lund Report. “I suspect 50% will meet that.”
But that efficacy rate will not stop the pandemic, experts say. And no one knows how many people will be willing to take the vaccine. The lower the efficacy rate, the higher the percentage of people who will need to be vaccinated to curb the pandemic.
One thing seems certain, public health officials warn: A vaccine will not be an immediate panacea. Even one with a high efficacy rate is not likely to end the pandemic like the flick of a light switch or the jab of an injection. Americans will continue to live in the shadow of COVID-19 for months after a vaccine is approved and distributed, state and national experts say.
Dozens Of Vaccines In The Works
Chinese scientists helped give the world an early start on a vaccine in January, a month after the outbreak started in Wuhan, by posting the virus’ genetic sequencing data on virolological.org, a website site for early findings. They called it Novel Coronavirus 2019 or SARS-CoV-2.
Genetic data in hand, vaccine specialists got to work. There are now 49 vaccine candidates being tested in human trials, according to the New York Times vaccine tracker, but only 10 have reached the final stages of testing. The U.S. government is financially backing six -- by Johnson & Johnson; Moderna; AstraZeneca and the University of Oxford; Novavax; Pfizer and BioNTech; and Sanofi and GlaxoSmithKline.
Trials are taking place across the country, including in Oregon. The Kaiser Permanente Center for Health Research in North Portland and a small allergy clinic in Medford, the Clinical Research Institute of Southern Oregon, are involved in late-stage testing of the Moderna candidate. Providence Cancer Institute in Portland announced Thursday that it is starting the first phase of testing of another vaccine on 36 people. This candidate is being developed by Providence researchers and the biotech companies OncoSec and UbiVac, it said in a news release.
Scientists hope the trials will produce good efficacy data, or proof that at least one works, in the next few months.
“I would be surprised if we didn’t have an efficacy signal by one of more of the major vaccines by early 2021,” Dr. Louis Picker, a leading vaccine researcher at Oregon Health & Science University, told The Lund Report. “This is unprecedented in terms of speed.”
Normally, it takes years to develop a vaccine, but the Trump administration has pushed for an early candidate.
Picker, who’s not involved in a COVID-19 vaccine, doesn’t like the political pressure put on scientists. But he said the involvement of the U.S. government, which has spent $10.7 billion so far on the development and manufacture of a COVID-19 vaccine, has been invaluable.
“This would never have happened without a big input of money,” Picker said. “I don’t like the fact that they seem to be moving so fast that not every funding decision was the best one, in my opinion. But it’s understandable. You want to go fast. You have to be willing to say, ‘OK, if we spend $10 billion dollars and it turns out that only $1 billion was worthwhile and the other was wasted but we get a vaccine by February 2021, then that’s just the way it goes.’”
Pharmaceutical Companies Try Different Approaches
Vaccines have been around since the end of the 18th century when the smallpox vaccine was pioneered by Dr. Edward Jenner, a British surgeon, who observed that milkmaids exposed to the catpox virus that causes cowpox developed immunity to the far deadlier variola virus that causes smallpox.
Vaccines generally all work the same: A vaccine introduces a pathogen to the body to train the immune system to develop antibodies and immune cells to fight against it.
The COVID-19 vaccines rely on several different approaches.
Two top contenders -- by Johnson & Johnson and AstraZeneca and the University of Oxford -- are so-called viral vector vaccines. These use a virus that is relatively harmless or rendered harmless as a vehicle to deliver genetic material to the cells from the virus that poses a threat. Once exposed to the vaccine, the body’s cells fire up the immune system to ward off an infection.
This approach has been used for about three decades. These vaccines are relatively inexpensive to make, and they’ve been tested on many people, Picker said. Though the technique has been used in an approved rabies vaccine for wild animals, it wasn't until 2019 that the FDA approved a viral vector vaccine against Ebola.
Two other leading candidates -- by Moderna, and Pfizer and BioNTech -- rely on a newer technology called messenger RNA or mRNA. This system delivers genetic material to the cells that prompt them to make a protein from the target pathogen. That tricks the cells into sensing that they’ve been infected, prompting an immune response against the target pathogen, in this case COVID.
These vaccines can be highly effective, Picker said, because they fire an immune response inside cells and spark a natural response to the RNA in the vaccine.
“The immune system doesn’t like to see RNA, so it responds to it,” Picker said. “It makes a nice antibody response to whatever the protein the RNA encodes for.”
These vaccines are relatively inexpensive to make, but they need to be kept frozen. They’re so new that they’ve not passed through enough clinical tests to be approved by the FDA.
“An RNA vaccine has not been in that many people,” Picker said. “There could be all sorts of things that crop up with giving a whole bunch of RNA to somebody that we can't predict.”
Novavax’s candidate is a so-called nanoparticle vaccine which uses chemicals to make a virus-like particle that replicates what the virus particle looks like to your body. This technique has been used to develop a number of cancer vaccines, for example against the human papilloma virus.
The last contender, by Sanofi and GlaxoSmithKline, uses a spike protein on the virus -- which is how the coronavirus gets into cells -- with a booster, to invade cells and fire up the immune system.
Picker said Sanofi and GlaxoSmithLine’s vaccine is promising.
“I like it because it is tried and true technology (developed for HIV vaccines) that is well tolerated and tends to give a very good response,” Picker said in an email, adding that he also likes the Johnson and Johnson vaccine being developed by a respected researcher.
“It's also a very strong vaccine that has been in lots of people in prior incarnations,” Picker said.
Oregon Will Review Federal Data
The Centers for Disease Control and Prevention, which sets vaccine schedules in the United States, will review the results of the clinical trials through its Advisory Committee on Immunization Practices. That panel, with experts in immunology, pediatrics and public health, guides CDC’s vaccine policies.
The FDA also has a review committee -- the Vaccines and Related Biological Products Advisory Committee -- that will scour the data and make a determination about approval. A green light would allow the vaccine to be distributed across the country.
The push by the White House to get a vaccine on the market has cast a shadow over the operation. A nationwide poll in August indicated that only 35% of those surveyed would get a COVID-19 vaccine. The Oregon Health Authority also conducted a survey, released in September, that showed that only 39% would get a COVID-19 vaccine.
Cieslak, Oregon’s infectious disease expert, is not worried about that tepid response.
“Although vaccine skepticism does tend to run high in Oregon, that’s mostly to do with diseases that we don’t see much of -- like polio and measles and rubella that are hardly seen anymore,” Cieslak said. “With COVID-19, the threat is evident. So I think people will be more willing than they would be with some other diseases to take the vaccine against it.”
Cieslak said the Oregon Health Authority will follow the CDC and FDA review process and examine the published vaccine data to be able to inform the public about how effective a vaccine is and any side effects.
“We’re going to be paying attention and reviewing the data and apprising ourselves of what the vaccine does and doesn’t do and the groups that it doesn’t work in as well as paying attention to local data on who is at highest risk for COVID,” Cieslak said.
Gov. Kate Brown announced on Tuesday that Oregon, Washington and Nevada will take part in California's COVID-19 Scientific Safety Review Workgroup, which will independently review the safety and efficacy of any vaccine approved by the FDA.
“The vaccines currently in development, once approved, are what Americans have been waiting for to protect their families, their children, and their loved ones in long-term care facilities,” Brown said in a statement. “The independent review conducted by this panel of doctors, scientists, and health experts will ensure that a safe and effective COVID-19 vaccine is available to everyone, especially communities that have been disproportionately impacted by this disease.”
It's unclear what impact an independent review would have. Even if officials rejected the FDA decision, they'd have difficulty preventing providers from obtaining it once supplies were widely available.
Officials in the FDA and CDC have said they would not rush a faulty vaccine to market just to yield to political pressure.
At the Heritage Foundation session this week, Dr. Matthew Hepburn, head of vaccine development in Operation Warp Speed, said the government will apply the same stringent criteria it always uses in vaccine approval.
“We are not cutting corners on safety,” Hepburn said. “We are not cutting corners on the quality of the manufactured product. Those are being done to the highest safety.”
Oregon Submits COVID-19 Plan
Earlier this month, the Oregon Health Authority submitted its COVID-19 vaccine plan. The 136-page document, which will be changed as the situation evolves, says the immunization of Oregonians will build on a ramped up flu vaccine campaign that’s already underway.
To ensure the widest distribution possible, the state intends to try some novel approaches, such as pop-up clinics, drive-through events and the use of emergency medical services to distribute an approved drug, Jonathan Modie, a spokesman for the Oregon Health Authority, told The Lund Report.
“These EMS vaccination clinics will be hosted in partnership with community-based organizations, local public health departments, tribes and other groups to supplement the traditional vaccine delivery system and build up the ability to bring (the) vaccine to communities,” Modie wrote in response to questions.
The plan says the state puts a priority on health equity by ensuring that groups most affected by COVID-19 have access to a vaccine. But that doesn’t mean that Hispanics, for example, who’ve accounted for nearly 40% of cases according to data published this week, will be vaccinated first.
Cieslak said Oregon will follow the CDC’s recommendations on priority groups and vaccinate health care workers first, followed by population groups with high COVID-19 death rates.
“We’ll be looking at elderly people and people with underlying health conditions, and then ultimately we will be looking at demographic groups that are at higher risk and critical infrastructure workers and finally to the entire population,” Cieslak said.
The state will use its immunization registry -- called Alert IIS -- to manage the vaccine supplies and their distribution. The system, which gathers patient immunization data, will be used by the health authority to allocate vaccine supplies and by providers to manage their inventory, Modie said. The system will also monitor who gets a shot and their demographic profile to measure how the state is doing on its equity goal.
In Multnomah County, officials are considering prioritizing health care workers in long-term care facilities to try to protect the elderly, Dr. Jennifer Vines, the county’s health officer, told The Lund Report.
State data show that nearly 60% of the deaths from COVID-19 involved people in long-term care and other residential facilities, with people 80 and over accounting for more than 50% of the deaths and those 70 and older accounting for 75% of the deaths even outside these facilities.
Vines said public health officials hope to learn from 2009 when the U.S. government pushed out a vaccine against the swine flu or H1N1 virus.
“What we learned from H1N1, or at least our experience with H1N1 is that the vaccine we would get would be in relatively small batches and not always on schedule,” Vines said. That meant selecting priorities within priority groups.
“The distribution will depend on how much vaccine we actually get, what the priority groups look like and how to get it to the right people,” Vines said.
Biggest Challenge Likely After Approval
The approval of a vaccine is not the biggest challenge, experts say. That’s the manufacture and distribution of enough doses to stem the pandemic worldwide.
“The hard part won’t be the science,” said Picker, the OHSU vaccine researcher. “I suspect all of these vaccines will work. The hard part is going to be effectively making 2 billion doses.”
Federal authorities have spent more than $8 billion, or about 75% of the money given out so far, on the manufacture and distribution of vaccines. That money has gone to the vaccine candidates developed by Pfizer, Johnson & Johnson, Moderna, and Sanofi and GlaxoSmithKline.
The government also has spent nearly $500 million on the manufacture of needles, syringes, vials and other supplies needed for a large-scale vaccination program.
In Oregon, an advisory group that’s being set up will include representatives of minority populations and other groups that have often been neglected by the health care system, to help with the logistics of ensuring that underrepresented groups have access to a vaccine.
“This group is really going to be advising on us on how we get the vaccine into the people we want to get it into,” Cieslak said.
All of the vaccines except the one developed by Johnson & Johnson will require two doses, so that adds another challenge for public health officials. They’ll need to track who received one dose and then to ensure that person is fully inoculated by getting the second shot. Oregon public health officials will rely on their ALERT system to keep track.
In addition, two of the vaccines being developed will need to be kept frozen until use, adding another complication. The mRNA vaccines developed by Pfizer and Moderna require extremely cold storage compared with traditional vaccines that only need to be refrigerated. If one or both are approved and not other vaccines are available, that could slow distribution, Cieslak said.
“Not many people will be capable of maintaining the product at that kind of temperature,” Cieslak said. “The distribution will go out from those fewer distribution points.”
The health authority’s vaccine plan includes scenarios for distributing a vaccine that requires hyper-cold storage, one that does not and the possibility that both types will be approved.
Though health officials are trying to plan for all contingencies, they face plenty of questions and concerns.
“I’m worried about priority groups and that we may not get enough vaccine at a time to get everyone within a priority group vaccinated, (forcing) the difficult decision on how to prioritize within those groups in a way that’s fair,” said Vines, of Multnomah County.
She’s also concerned about public expectations. A recent study published in the American Journal of Preventive Medicine looked at how effective a vaccine needs to be to stop the pandemic.
Its conclusions are sobering.
Simulations revealed that a vaccine with a 60% efficacy rate would have to be given to 100% of the population to extinguish an ongoing COVID-19 epidemic. A vaccine with an efficacy rate of 80% would require that 75% of the public is inoculated.
That study indicates what many health officials are saying: COVID-19 will not go away easily. And no one knows yet how long immunity from a vaccine might last. Though the virus doesn’t mutate rapidly, like the flu virus for instance, the effectiveness of a vaccine could fade over time.
Health experts say the public will need to continue wearing masks and keeping a distance of at least 6 feet from strangers or people outside their households for perhaps months to come.
“We’re going to find ourselves in some kind of transition period with some people vaccinated, many people not, everybody needing to continue some kind of face coverings and social distancing until we reach that pretty high threshold of vaccine coverage,” Vines said. “Then hopefully restrictions will be peeled away slowly.”
You can reach Lynne Terry at [email protected] or on Twitter @LynnePDX.
