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The Biden administration’s plan was that everyone over age 16 would be eligible for COVID-19 vaccine booster shots starting today. That may happen someday, but for now, the United States is moving toward only officially offering boosters for seniors, people who are constantly exposed to the virus (like health workers) and those with health conditions that compromise immune response.
Journalists, be careful not to signal that there is concern about whether vaccines are safe and effective. In fact, it is the opposite. The Food and Drug Administration advisory committee that did not recommend booster shots for everyone said, in effect, that the vaccines are working well and there is no proof that a booster is needed except for the most vulnerable populations.
The advisory panel voted against recommending booster shots for everyone on Friday, but there is more to come. On Wednesday and Thursday, the Centers for Disease Control and Prevention will consider the need for and safety of booster shots. The FDA authorizes vaccines as safe and effective for use, but the CDC sets vaccine policy and makes recommendations for how the public should use them.
The vote last week is just the second step in the graphic below. This week, the FDA will decide whether to accept the advisory committee recommendation, and it usually does.
The FDA advisory panel asked the panel — the Advisory Committee on Immunization Practices, which advises the CDC — to look at whether there is sufficient data to recommend that people who are most likely to be exposed to COVID-19 take a booster shot. That could apply, for example, to health care workers. So there is significant booster news still ahead this week. The advisory committee included representatives from the CDC and the National Institutes of Health who voted against the booster shots for everyone, which may signal that the CDC will line up the same way.
However — and this is a big however — just hours before Friday’s FDA advisory committee meeting, the CDC released data that show the Pfizer vaccine’s effectiveness drops significantly four months after vaccination. The study, based on 3,700 patients, found the vaccine was 91% effective initially but dropped to 77% effective. The study found the Moderna vaccine did not have the same rate of decline in its ability to protect people against the virus. The study did not have enough data to similarly evaluate the Johnson & Johnson vaccine.
Since the FDA committee did not have time to digest this study, it is unknown if it would have made any difference in the outcome. But the CDC, having produced the study, will have something new to consider when it meets this week.
There are a number of ways the booster shot story can be legitimately framed in your news coverage this week:
- The FDA refused to rush: This could be reassuring to people who criticize the government for pushing vaccines through the approval process too quickly.
- The FDA pushed back on politicians: President Joe Biden wanted the booster shots to start rolling out for everyone this week, but the FDA flexed its muscle to show science, not politics, leads vaccination decisions. It could be framed as a Biden defeat, or it could be framed as Biden making a suggestion but allowing the experts to make the final decision without a bitter public battle over the optics.
- The FDA is not afraid to say no to big drug companies: Pfizer would make millions of dollars from widespread booster dose sales.
- The Vaccines and Related Biological Products Advisory Committee is independent of the FDA: The vote last week shows the committee demands deep data before it approves a vaccine. That could bolster the public’s trust in the vaccine approval process.
- The vaccines don’t need much help; they already work very well: The most important takeaway from the advisory panel’s vote is that the Pfizer vaccine is effective, protects people from severe illness and generally does not need to be boosted for young and healthy people. In this story frame, the FDA advisory committee strongly supports the two-dose vaccine.
What evidence does the FDA advisory committee want that Pfizer could not supply?
I hope this is not too wonky, but I want to spend a few lines explaining what the advisory panel wanted to know about boosters but could not discern from the volumes of data that Pfizer supplied.
The committee asked about side effects from a third shot. The experience in Israel, where boosters are widespread, is that most people had the same symptoms that showed up with the first two doses, including mild soreness, some headaches, fatigue and chills.
The vaccine advisory committee wanted to see Pfizer’s data that showed the vaccine would be safe, especially for younger people. The committee asked about a heart inflammation issue called myocarditis, which has shown up rarely among young males who got the vaccine. Pfizer has very little data on how often a booster shot was associated with myocarditis. Israel documented one case out of the million booster shots given that possibly is connected. But even that case was a 30-year-old man.
Immunologist Dr. Katelyn Jetelina explains why the committee was dissatisfied with the Pfizer data:
The Pfizer clinical trial of 3rd shots was very small sample (~300 people). So, no reassurance was provided for myocarditis. But, unfortunately, this is only really able to be answered post-licensure approval. Vaccine-induced myocarditis is so rare that we need millions of people vaccinated to see the “true” effect. An in-depth benefit-risk analysis could provide insight into whether the benefit of vaccinating younger with a 3rd dose is better than the risk of potential myocarditis from a 3rd dose. This was missing from the presentations Friday.
Committee member Dr. Paul Offit said committee members wanted proof that a booster shot would cause more good than potential harm and, at the moment, there is no convincing need for a booster for most people.
What did we learn from Israeli health authorities about booster shots?
Pfizer argued for booster shots, but you could be skeptical since they would profit from such a decision. The more compelling data came from Israeli health officials who presented an analysis of why Israel launched a booster campaign and what happened when they did.
Two charts tell their story. The first chart was Israel’s projection of how a third COVID-19 wave would unfold without a booster campaign and how it actually unfolded.
Israel was experiencing a rapid rise in new cases, even among vaccinated seniors. But shortly after the country began offering booster shots, there was a steep drop in new cases among seniors even while new cases among the unvaccinated continued to climb. The nearly tenfold increase in new cases dropped to fewer than half that after booster shots began.
Dr. Paul Offit said America’s experience with the two-dose vaccines is different from Israel’s experience. Offit said the U.S. experience is that the two doses have not waned the same way as the Israelis found.
What’s next for booster shots?
Back in August, the CDC authorized booster shots for some immunocompromised people. That followed the FDA’s emergency use approval that said it was “specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.”
The CDC will consider the data independently this week. If the CDC approves boosters for seniors and health care workers, booster vaccinations could begin quickly since there are ample supplies of vaccines available in the United States.
Soon, all of this multi-tiered review will replay when Moderna’s request for booster approval comes before the FDA and CDC. Sometime in the future, Johnson & Johnson will also likely ask for similar consideration.
COVID infections spreading in jails, again
One of the great disappointments of the pandemic is how jails and prisons found ways to release nonviolent prisoners and relieve crowded and infected jails but that jails are now refilling and COVID-19 is coming back.
In Monterey County, California, COVID-19 cases in the jail quadrupled in the last week. That, of course, endangers staff as well as other incarcerated people.
The Marshall Project reports that more than a half-million people got COVID-19 in prisons. Add to that the cases in county and regional jails and the many cases where people were sick but never tested. Marshall reports:
While many jails emptied out during the pandemic and prison populations declined, the criminal justice system has not fundamentally changed. Lauren Brinkley-Rubinstein, who leads the COVID Prison Project, said she hasn’t seen the systemic change needed to address the next pandemic.
“What we’re seeing over the past couple weeks and months is a real return to status quo, which makes me worry that prisons and jails didn’t learn much at all,” Brinkley-Rubinstein said. “I see incarcerated populations returning to what they were before.”
Employee shortages plague many prisons. The federal system is at critically low levels and has been forced to make teachers and others watch prisoners. The Nebraska prison system recently declared a staffing emergency at a fourth facility, and Texas prisons are struggling with more than 5,000 correctional officer vacancies and the lowest staffing levels in recent memory.
In Pennsylvania, transfers and insufficient quarantine policies contributed to spreading the virus between prison facilities, said John Eckenrode, president of the Pennsylvania State Corrections Officers Association. Once there were active cases throughout the state’s prisons, including among staff, the department became lax with quarantining and actively contact-tracing staff after someone tested positive.
Starting Wednesday, I will lead another in our series of Poynter workshops on Covering Jails and Police Reform. For the last four years, we have traveled the country presenting these workshops to hundreds of journalists to help them cover justice reform stories, focusing particularly on jails. We meet live, virtually, every Wednesday for six weeks. It is open to all journalists and tuition is covered by a grant from the MacArthur Foundation.
We are asking you to seriously commit to attending all of the sessions. Our graduates have proven that these classes can result in significant and thoughtful coverage of critical jail and justice stories. Our plan is to go back on the road with these sessions in 2022.
The Haitian trail to the Texas border
13,000 Haitians are risking their lives and living in squalor on the Mexico-Texas border. It may surprise you that Haitians, not Central Americans, are making the journey this time. It may also be news to your audiences that these migrants are Haitians, but it has been building for months. Voice of America traced the trail back to the Olympics in Rio four years ago:
As construction jobs for the 2016 Summer Olympics in Rio de Janeiro ended and Brazil descended into political turmoil, many Haitians crossed 10 countries by plane, boat, bus and foot to get to San Diego, where U.S. authorities let them in on humanitarian grounds. But then-President Barack Obama shifted course and began deporting Haitian arrivals in 2016. Many then started calling Mexico home.
Haitian restaurants opened in Tijuana, across the border from San Diego, serving mangoes and mashed plantains. Factories that export to the U.S. recruited Haitians, who also wait tables and worship at congregations that have added services in Creole.
In recent months, some Haitians have moved from Tijuana to Ciudad Juarez, another large border city with jobs at export-driven factories. They’re driven by job prospects, hopes of less racial discrimination and a temptation to cross what they perceive to be less-guarded stretches of border.
To get an idea of what this trip from South America to Texas involves, take a look at this documentary by PBS NewsHour. The team walks the footsteps across the Darien Gap, the miles and miles of thick forest and mountains where South America meets Central America. The migrants have no map, no promise they will make it through raging rivers and increasingly hostile border authorities. Add to it snakes, paramilitary groups and other smugglers who are guiding groups through weeks of desperation. The trail is dotted with desperate people who got there from Africa, the Middle East and Haiti. Watch the video and it will put the scene at the border in context. They have endured so much to get to that bridge.
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