Monday’s news from Pfizer and German partner BioNTech that the vaccine against the novel coronavirus they’ve developed is more than 90 percent effective was greeted with public glee and a skyrocketing stock market. What’s next: Pfizer detected the good response in 94 trial participants; after that number reaches 164 — which it expects to come in the third week in November — it will apply to the Food and Drug Administration for Emergency Use Authorization for distribution.
The FDA will then turn the application over to its Vaccine and Related Biological Products Advisory Committee to review Pfizer’s data on safety and efficacy and recommend whether it should be licensed. The decision to license then goes to the director of the FDA, who in turn will make a recommendation to the secretary of the U.S. Department of Health and Human Services.
Once the drug is approved, Gen. Gustave Perna, head of Operation Warp Speed, which is stockpiling vaccines purchased ahead of time by the U.S. government, said the vaccine and kits of needles, syringes and alcohol could be shipped within 24 to 48 hours to hospitals, pharmacies and other providers who have applied for supplies.
Pfizer said in a press release Monday that it expects to distribute up 50 million doses globally before the end of the year, and up to 1.3 billion doses in 2021. The Trump administration has agreed to pay Pfizer $1.9 billion for 100 million doses; that means those doses will be provided at no cost to American consumers. (Pfizer received no funding to develop its vaccine from Operation Warp Speed; Germany footed that bill.)
Another committee will look at the Pfizer data to determine its safety and efficacy and how it should best be used. That’s the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), which is chaired by Arkansas’s Secretary of Health, Dr. Jose Romero. The 15-member ACIP panel, the only nongovernmental committee that makes U.S. policy, will review Pfizer’s data, either simultaneously with VRBPAC or at an emergency meeting within 48 hours of licensure, to assess safety, efficacy across populations and make recommendations to the CDC on what populations should receive the drug first. It’s a given that the first persons to receive the vaccine, since it will be in limited supply, will be people working in hospitals, from doctors to janitors. The Arkansas Department of Health is identifying which hospitals should get the vaccine in the first year, based on their COVID-19 patient load, beds, storage ability and a number of other factors, and will submit that list to Operation Warp Speed, which takes population into account on how much to allocate to the state. The health department’s Vaccine Medical Advisory Committee will review the ACIP’s recommendations and advise Romero how they should be applied in Arkansas. (That process should be expedited, given that Romero is both the chair of ACIP and, as Arkansas’s secretary of health, aware of the state’s needs.)
Hospitals already identified as priority recipients include Baptist Health in Little Rock, NEA Baptist Memorial Hospital in Jonesboro, St. Bernards Medical Center in Jonesboro, the University of Arkansas for Medical Sciences and Washington Regional Medical Center in Fayetteville. Romero said he expects that list to grow to 10 hospitals.
After health care workers are taken care of, the CDC is likely to prioritize people most at risk for contracting the disease, including people over 65 and persons with health conditions that make them vulnerable to bad outcomes from the virus. It’s possible, however, the Pfizer vaccine won’t be recommended for people over 65. Not all vaccines are equal. Because of their weaker immune systems, older people will need a high-dose vaccine, just as they do for the influenza vaccine. (The FDA wants evidence that the vaccines will work in at least 50 percent of those who receive it.)
ACIP’s independent review of the data “offers further security, further safety evaluation,” Romero said Tuesday. “While we trust what the FDA says, we conduct our own evaluation to make sure nothing is missed.”
Vaccines determined to be safe and important for public health by ACIP — flu shots; measles, mumps and rubella; hepatitis A and B, etc. — should be covered by insurance or offered for free.
Arkansas’s “COVID-19 Vaccination Plan” — which is in draft form now — puts distribution in phases: Phase 1-A will target health professionals, clinics, health units, first responders and “essential government leaders.” Phase 1-B will cover people at risk of severe illness, which, besides older people and those with underlying medical conditions, includes teachers and other school personnel, daycare employees, law enforcement, meatpacking plant workers (particularly poultry), elected and other officials, and government employees.
Phase 2, which will kick in when more doses of vaccine are available, will apply to those eligible previously but not covered, clinics, pharmacies, infrastructure workers such as grocery store employees, manufacturing plants, residents of long-term care facilities and other congregate settings, and university employees. The state will begin mass vaccinations at this point, probably drive-through, health department spokesman Gavin Lesnick said.
Phase 3 kicks in when vaccine supplies are sufficient to immunize the entire population of the state, perhaps by March or April, and mass vaccination will continue.
The Pfizer vaccine uses messenger RNA — a bit of the coronavirus genetic material — to teach the body’s immune system to recognize and kill it, and will require two shots 21 days apart.
If it gets to the finish line first — which a review of The New York Times’ Coronavirus Vaccine Tracker suggests — its distribution will be restricted to institutions that can store it at -70 degrees Celsius (some sources say it will need to be even colder, at -80 C.). That will limit distribution; many smaller pharmacies and rural hospitals do not have that kind of refrigeration. However, Health and Human Services and the Department of Defense have contracts to distribute to large chain pharmacies. Pfizer intends to deliver it directly to qualifying institutions on dry ice in special containers.
It’s not yet known if this is the best vaccine for older people or children, though Pfizer began to enroll children as young as 12 in September in its clinical trial.
Dr. Jennifer Dillaha, the state epidemiologist, told a legislative committee in October that a minimum order for Pfizer vaccine will be a tray of 975 doses, “so smaller health care organizations will not be ordering that.”
Moderna, which got $953 million from the federal government to support research and clinical trials and like Pfizer is in phase 3 human trials, is also testing a messenger RNA vaccine. Its clinical trials include people 65 and older, so if approved it may be suitable for that population. If the vaccine is approved, the U.S. will buy 100 million doses for $1.5 billion. Moderna’s vaccine only requires a -20 C. freezer, and its minimum is 100 doses, Dillaha said. The company has said it may know by this month if its vaccine works. Moderna said it may apply for Emergency Use Authorization by the end of the year.
Also in its phase 3 trial is Johnson & Johnson’s adenovirus-based vaccine. That vaccine requires only one dose, and doesn’t need deep-freeze refrigeration. The company halted testing for a couple of weeks after a volunteer became ill, but resumed after determining the vaccine was not the cause. The federal government has invested $1 billion in the drug and will own the first 100 million doses. According to the Times tracker, it expects to have results by the end of 2020.
Clinical trials of AstraZeneca’s vaccine, which uses a chimpanzee adenovirus to trigger an immune response, were halted in the U.S. after two volunteers abroad fell ill with neurological symptoms. However, trials have resumed and the company has said it expects results by December. AstraZeneca has been awarded $1.2 billion by the U.S. for 300 million doses. The company has also received federal funding to develop a monoclonal antibody for treatment or prevention, a drug that can be used in people with compromised immune systems or are elderly.
The U.S. has also invested $1.6 billion in the Maryland company Novavax. That vaccine, which attaches proteins to microscopic particles, has not yet entered the final, phase 3 clinical trials in the U.S. The government will own more than 100 million doses. If the vaccine proves safe and effective, the company plans to deliver to the U.S. in the first quarter of 2021.
China has approved an adenovirus for its military. Russia has developed a vaccine,
“Sputnik V,” which it has announced as proving effective in 20 people.
Now, the state needs to convince people to become immunized.
“The greater population we have [immunized], the greater chance we have to stop the virus,” Romero said. For herd immunity — to deprive the virus of a sufficient population in which to survive — the state will need to vaccinate around 65 percent of its residents, he said. Romero noted, however, the state’s poor record in getting people to get flu shots. “It’s an ongoing issue,” he said; fewer than 50 percent of the state’s adult population get flu shots year to year. “People view themselves as healthy,” he said, and there is a misconception that the shot can give people the flu.
A survey conducted Oct. 3-17 by the University of Arkansas for Medical Sciences’ Fay W. Boozman College of Public Health found what it called only a “tepid response” from the public to a COVID-19 vaccine. Using a scale of 1 to 10, with 10 being total support, responses averaged at 5.0, “slightly better than agree or disagree” that one should be immunized. The survey, which included 1,100 people, found that trust that the vaccine would be safe was lowest among Black respondents by a significant margin. That is perhaps to be expected in a population that has been treated poorly by government health officials, such as the Tuskegee Study in 1932 that infected Black men with syphilis and lied to them and denied them treatment. Subsequently, trust in the polio vaccine was lower among Blacks.
The study also found that the more respondents agreed with mask-wearing and other behaviors to stop the spread, the greater their confidence in a vaccine.
It’s important for the state, Romero said, to convey the facts about vaccines and how the U.S. regulates them. The pharmaceutical data is “scrutinized very carefully” before licensure, and as part of the post-licensure phase 4, the FDA continues its review of vaccines for safety and efficacy, gathering data generated as more and more people are immunized.
Romero insisted that there is no political influence on the expert panels judging the drugs for their safety and efficacy. “I have not seen pressure, nor felt pressure, from any organization or the government to rule one way or another on the vaccine. As a matter of fact, what you are seeing is more and more pharmaceutical companies coming out and saying, ‘We will not move forward unless we see safety and efficacy.’ ” That the companies deemed it necessary to make such statements says a lot about President Trump’s promise of a vaccine before Election Day.
Asked at a recent press conference how the state will try to convince people of the need to vaccinate, Governor Hutchinson said he’d expressed to Health and Human Services Secretary Alex Azar the need for marketing the vaccine. “Confidence level in a vaccine is critically important to people accepting it. The people of Arkansas are cautious. They want to make sure the FDA is following all its protocols,” he said. The governor said he expects the tepid response to become “warm.”