Epidemiologist: ‘We should be giving away patents’

By Jessica Firger, CNN

For his two-dose Pfizer Covid-19 vaccine, Ted Rall crossed state lines back in February and March. Appointments in New York City were impossible to come by, but his friend told him about a federal facility in New Jersey with no residency requirements and so he drove there twice.

The Covid-19 shot Rall had at the end of July — his third — was a lot easier to get his hands on and far more convenient, he says, even though the US Food and Drug Administration and the US Centers for Disease Control and Prevention don’t currently recommend Covid-19 vaccine boosters for anyone.

Rall, 57, simply walked into a CVS pharmacy in Manhattan, no appointment needed, and told the pharmacist he wanted to get a Covid-19 vaccine. He pretended it was his first dose.

Rall, a political cartoonist and writer, says he has asthma and a history of serious respiratory disease including swine flu and pneumonia. He suspects he had Covid-19 early in the pandemic, though his antibody tests were negative. He isn’t interested in taking any chances now that the more transmissible Delta variant is ravaging the country and more than 98% of the US population lives in counties considered to have “high” or “substantial” Covid-19 transmission, according to the CDC.

“I want to stay protected, you know, and I think it’s also pretty obvious that this is going to be the norm, and it might just be like in a month or two,” Rall told CNN. “Everyone’s going to be doing it, so why wait until it’s hard to get appointments again?”

Rall could be right about the timeline. A Biden administration official told CNN last week that internal discussions at the FDA are looking at early September to lay out a strategy on Covid-19 booster shots. A decision for those who are immunocompromised and face greater risk from the virus is expected sooner, the official said.

Vaccine advisers to the US Centers for Disease Control and Prevention will meet Friday to discuss boosters and additional doses for immunocompromised people.

And the FDA is already considering full approval of the Pfizer Covid-19 vaccine, a decision that some say could occur in a matter of weeks. All of the Covid-19 vaccines are currently available in the US under emergency use authorization. Full approval could mean that the fully vaccinated could get an additional vaccine — well before any recommendation for boosters — if a doctor thinks it’s warranted.

The available vaccines provide strong protection for most people, but studies have shown that people who are immocompromised don’t build up sufficient protection from the standard doses of Covid-19 vaccines. Recent research also suggests that some protection from mRNA vaccines wanes for everyone over time.

Dr. Eric Topol, a cardiologist and professor of molecular medicine at Scripps Research, told CNN he predicts that an FDA approval, plus a direct message that boosting is necessary — even if it’s strictly for immunocompromised people and the elderly — will create a sort of “booster mania” in the US.

He said an FDA approval “opens up everything for people who are concerned to get a doctor’s prescription. So that just adds to the chaos.”

‘We’re not there yet’ on boosters

Rall’s own decision to seek out a booster was driven by all of the research he’s read about, including data from the Israeli Health Ministry released last month that suggests that overall efficacy of the Pfizer vaccine against all Covid-19 infections has dropped to just 39% in those who were vaccinated earlier in the year, although their data show the vaccine is still 91.4% effective in preventing severe disease.

Other data released by both Pfizer/BioNTech and Moderna suggest that both vaccines see waning levels of antibodies over time.

But that doesn’t mean protection ends, and boosters aren’t yet recommended for anyone.

On Sunday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Fareed Zakaria that there’s still limited data on how long vaccine durability lasts.

“The bottom line of it all is that we are following very carefully the durability of protection,” Fauci said. “And when you follow it, you look and see what is the percentage of protection that you get as you go month for month.”

When data shows protection goes below a certain threshold, he said, health officials will recommend boosters for the general population.

Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Pennsylvania, said Tuesday during a conversation hosted by Brown University that he thinks “we will cross the line, where we know we need a booster dose, when people who are vaccinated, fully vaccinated, nonetheless, are hospitalized or in the ICU or dying.

“We’re not there yet.”

So far, the vaccines are working: A CNN analysis of CDC data suggests more than 99.9% of fully vaccinated people have not had a severe breakthrough infection.

It’s also not clear what risks could come with an additional shot. Topol says it’s best to sit it out a few more weeks and he cautions that people who just want to go out for a booster should consider the potential side effects.

“We don’t know the boosters are going to protect. These boosters are directed against the original strain, the same problem we have with a vaccine,” Topol says. “They’re going to raise neutralizing antibodies in people over weeks and they will help to some extent, but we don’t know how much, because they’re not directed to Delta.”

Rall, who recently wrote for the Wall Street Journal about his experience getting a booster shot, says he wasn’t worried about the potential risks at all.

“If you told me this vaccine would kill me in 10 years, I would go and take it right now because it’s that or this horrible Delta variant going around, and I don’t think I would survive that,” he said.

And it wasn’t hard for him to get a booster — Rall says the pharmacy didn’t ask him a single question, nor did it look up his immunization records.

When asked how CVS determines whether someone who comes to one of the pharmacies or MinuteClinics to get a Covid-19 vaccine hasn’t been vaccinated already, a spokesperson for the company said that “patients who have been fully vaccinated at a CVS Pharmacy, or who inform us that they were fully vaccinated by another provider, will not receive another vaccine under the current CDC guidelines. In certain cases, pharmacists may also be able to check a patient’s vaccination status with a state’s vaccine registry.”

CVS wouldn’t have been able to figure out Rall had already been fully vaccinated in New Jersey because immunization registries are managed by the state and he got his third shot in New York.

Rebecca Coyle, executive director of the American Immunization Registry Association, said states are currently backlogged with larger-than-normal amounts of immunization information — and it’s up to states to make agreements to share immunization data with each other.

“Not to point out a loophole, but we do not have good data exchange across state lines at this point,” she said.

Booster plans in progress

While some individuals are seeking out boosters, some places are making plans to boost vaccines for certain people.

The city of San Francisco is accommodating people who received the one-shot Johnson & Johnson coronavirus vaccine and would like to receive a supplemental dose of either the Pfizer or Moderna vaccines. Officials in the city’s Department of Public Health said last week that the department is making an “accommodation” for those who have consulted with a physician, and it is not recommending extra doses or a policy change.

In an email to CNN, Dr. Peter Hotez, dean of Tropical Medicine at Baylor College of Medicine, said he believes the US will move to third mRNA and possibly second J&J shots relatively soon for people having immunosuppressive therapy, especially solid organ transplant recipients, and the next question will be what other immunocompromised conditions will also be included. After, the next question will be if the US wants to add boosters for people over age 60 — as Israel has just announced it plans to do.

Germany, the United Kingdom and France also announced booster programs for their most vulnerable populations, even though the World Health Organization last week called for a moratorium on booster shots through at least September until vaccines can be distributed more equitably worldwide.

That’s a great irony to Rall, who says that he wouldn’t have considered seeking out a third shot if it weren’t clear that a lot are going unused by vaccine hesitant populations, particularly in the South.

“But even locally here in New York when I talked to local physicians and pharmacists, they all have lots of unused vaccines, and I thought, well this is ridiculous.”

Rall says since sharing his experience with others he’s heard from physicians that say they have quietly used vaccine doses as boosters that were set to expire on themselves and for their family members, and that they’ve been doing so for months. “There’s an underground there, there’s a lot of doctors who have access to these doses, and they’re using them rather than throwing them away.”

Those close to Rall weren’t all that surprised by his decision to get a booster shot. “Friends kind of know that I’m an independent thinker, I kind of don’t really care about or have much respect for sort of one’s ‘official conclusions’ coming from policymakers because. I know that the policymakers are trying to save as many people as possible, as low cost as possible. That’s their job.”

“I, first and foremost, care about me, so I have a different calculus.”

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Virginia Langmaid, Jen Christensen, Jacqueline Howard, Hannah Ritchie and Niamh Kennedy contributed to this report