Covering COVID-19 is a daily Poynter briefing of story ideas about the coronavirus and other timely topics for journalists, written by senior faculty Al Tompkins. Sign up here to have it delivered to your inbox every weekday morning.
It appears that the U.S. Food and Drug Administration will beat its goal of giving the first COVID-19 vaccine full approval by Labor Day. The agency is preparing to declare the Pfizer vaccine safe and effective and remove it from being administered under an emergency approval order.
The approval may arrive today or in the next few days as the agency works through a mountain of data from hundreds of millions of vaccines delivered.
The status removes one more barrier that vaccine skeptics have to taking the vaccine. A recent poll by the Kaiser Family Foundation found the lack of full FDA approval is a key reason that people who are unvaccinated give for not taking the shot. The newest polling shows:
- Three in ten of the unvaccinated ( 31%) report that they would be more likely to get vaccinated if the FDA moved vaccines from emergency use to full approval. That’s because many unvaccinated people worry that the vaccines are experimental and fears about the safety of the vaccine are a major reason some groups are hesitant to get vaccinated. FDA approval offers an opportunity to aggressively address safety and efficacy concerns. Lack of FDA approval has allowed the idea that the vaccines are unsafe or ineffective to fester.
- More than half of the unvaccinated are also unsure what the status of FDA approval is. Approval also offers an opportunity to clear up substantial public confusion.
- Some employers who have imposed vaccine mandates, including hospitals, have faced blowback from some employees. Approval will provide justification and cover for them.
- And most important of all, it can boost vaccinations by emboldening more local governments and employers to move ahead with passports and mandates. Education Secretary Cardona underscored the point in a recent Washington Post interview: “I would favor the vaccine being required but … having the FDA do the final approval on it would make some who don’t feel comfortable feel comfortable.”
- Once the FDA gives approval, you can count on government- and employer-sponsored campaigns that stress the full approval as a new reason to get vaccinated.
The committee that will consider full FDA approval is the Vaccines and Related Biological Products Advisory Committee. The committee posts research materials and live feeds of meetings to this FDA website. These are the committee members. Check the list because they are from all over the country and might be near you.
What is the difference between emergency approval and full FDA approval?
Let’s get you caught up on the terminology you will hear a lot in the next couple of days. Pfizer applied for a Biologics License Application, or BLA — which would mean full approval. When the company applied for full approval, BioNTech CEO Dr. Uğur Şahin said, “Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future.”
A year ago, Pfizer and Moderna collected data from tens of thousands of volunteers, half of whom took the vaccine and half of whom got placebos. The Pfizer trial involved 43,000 participants, while 30,400 people took part in the Moderna trial.
Emergency use approval required the drug companies to follow the volunteers for two months after vaccination. Experts say two months is usually enough to know what reactions we can expect from a vaccine.
But full approval requires at least six months of data. Massive amounts of evidence are collected that can lead the FDA to issue warnings for possible side effects, as it has done with the Johnson & Johnson vaccine. The FDA once required the drug companies to complete their data collection and submit it, but now the FDA has a “Fast Track” system that allows companies to collect and submit data on a rolling basis to speed the time it takes to get medicines and treatments to market faster.
FDA approval does not change who should take the vaccine. It still will not likely be approved for younger children since those drug trials are still underway.
But full approval would also allow Pfizer to directly market the vaccine to the public. For example, all of those pharmaceuticals that you see in TV commercials required that the FDA fully approved those drugs first.
Full approval also pretty much closes the door on any other companies who come up with new vaccines and want fast approval. The FDA’s rules spell out that emergency approval is only given when “there is no adequate, approved, and available alternative.” And full approval allows the Pfizer vaccine to remain available even when the official “emergency” ends.
CDC delays meeting on boosters
Don’t read more into this than we know, but the Centers for Disease Control and Prevention advisory board that looks at vaccines had planned to meet Tuesday to consider approving COVID-19 booster shots for everyone who has been vaccinated. Now that meeting has been delayed for a week.
Jumping the line for COVID boosters
You knew that, as soon as the Biden administration announced last week that it would ask the FDA and CDC to approve COVID-19 booster shots eight months after people were vaccinated, some people would try to jump the line and grab their third shot ahead of everyone else.
But Dr. Anthony Fauci said people would be wise to wait the full eight months to give their immune systems a chance to “mature” before getting a booster.
Deepta Bhattacharya, professor of immunobiology at the University of Arizona, echoed Fauci’s comments, telling NBC News that getting a booster soon after a second shot “raises the possibility that it won’t work that well.”
He explained that third doses will likely work much better after fully vaccinated people lose some of the antibodies in their systems. He was quick to add that people will need to balance that likelihood “against the risk that your protection is reduced during the interval between shots.”
By the way, CDC Director Dr. Rochelle Walensky said, at this time, she does not think you will be getting annual COVID-19 shots. But, she said, “This virus has been humbling, so I don’t want to say never, but we are not necessarily anticipating that you will need this annually.”
Why did one city ask people to cut back on water to help hospitals treat COVID patients?
I had to dig around a little to understand this one. The city of Orlando asked people to cut back on their water use to help hospitals treat COVID-19 patients.
Linda Ferrone of the Orlando Utilities Commission and Orlando Mayor Buddy Dyer told people in Orlando that the city uses liquid oxygen to purify water, but right now that oxygen is needed to treat COVID-19 patients in hospitals.
The city is asking people not to water their lawns or wash their cars for a couple of weeks.
Mayor Dyer said nationally the demand for liquid oxygen is high and supplies are tight. He said the city is not in an oxygen emergency yet but didn’t want to wait until there was a critical shortage.
Orlando is far from alone in this situation. Other places that have been overrun with new cases, like Alabama, have run short of liquid oxygen, too.
People using ivermectin for COVID, leading to a spike in poisonings
Those of us who grew up around Kentucky horse farms know the drug ivermectin as a horse dewormer medication. Whoever started the rumor that that drug could fight COVID-19 is now responsible for a spike of poisonings.
In fact, the Mississippi State Department of Health sent out a warning saying, “The Mississippi Poison Control Center has received an increasing number of calls from individuals with potential ivermectin exposure taken to treat or prevent COVID-19 infection. At least 70% of the recent calls have been related to ingestion of livestock or animal formulations of ivermectin purchased at livestock supply centers. 85% of the callers had mild symptoms, but one individual was instructed to seek further evaluation due to the amount of ivermectin reportedly ingested.”
Let’s be clear, livestock drugs are made for livestock. They are highly concentrated and can be really dangerous to humans.
School changes dress code to sidestep governor’s order against mask mandates
When the school district in Paris, Texas, wanted to require students to wear masks, it found itself in a showdown with the governor who, despite testing positive himself recently, opposes mask mandates. So the school district changed its dress code.
Dennis Eichelbaum, Paris Independent School District general counsel, said it is not a loophole. He said, “Mandating masks is really no different than mandating shoes or other protective gear that we require.”
By the way, Gov. Greg Abbott said over the weekend that he has tested “negative” for the virus and credits the vaccine for the brevity of his illness.
Catholic bishops refuse to issue religious exemptions for vaccine mandates
It seems that most places that are imposing COVID-19 vaccine mandates leave open a small window for people who have religious or health exemptions that prevent them from taking the vaccine. But now, several Catholic archdioceses are refusing to issue such exemptions for parishioners who ask. Axios says:
Though the Vatican says getting the vaccine is “morally acceptable,” some bishops have argued that vaccination is not a moral obligation and must be voluntary.
At least five other diocese — including San Diego, New York, Los Angeles, Honolulu and Camden, N.J. — have issued similar guidance, while other bishops and Catholic organizations have publicly backed parishioners seeking exemptions for reasons of conscience.
In Lexington, Ky., employees at the Catholic Center of the Catholic Diocese of Lexington will be required to be vaccinated against COVID-19, Bishop John Stowe announced this week.
CDC’s new cruise ship warnings
Just as the cruise industry was starting to get its sea legs back, the CDC issued new warnings to older adults, pregnant people and people with certain medical conditions.
Until now, the CDC’s guidance was mostly aimed at unvaccinated people. The new guidance says COVID-19 can spread easily between people in close quarters on ships, and the chance of getting the virus on cruise ships is “high.” Here is CDC’s newest alert:
Key Information for Cruise Ship Travelers
- The virus that causes COVID-19 spreads easily between people in close quarters aboard ships, and the chance of getting COVID-19 on cruise ships is high. Outbreaks of COVID-19 have been reported on cruise ships.
- CDC recommends that people who are not fully vaccinated avoid travel on cruise ships, including river cruises, worldwide.
- People with an increased risk of severe illness should also avoid travel on cruise ships, including river cruises, regardless of vaccination status.
- People who decide to go on a cruise should get tested 1–3 days before their trip and 3–5 days after their trip, regardless of vaccination status.
- Along with testing, passengers who are not fully vaccinated should self-quarantine for 7 days after cruise travel, even if they test negative. If they do not get tested, they should self-quarantine for 10 days after cruise travel.
- People on cruise ships should wear a mask to keep their nose and mouth covered when in shared spaces. While CDC’s Mask Order is not being enforced on cruise ships, individual cruise lines may require travelers (passengers and crew) to wear masks indoors on board the ship.
COVID-19 outbreaks have been reported on cruise ships in recent months, despite various testing and vaccination requirements among cruise lines.
In July, four vaccinated adults and two unvaccinated children tested positive for COVID-19 on a Royal Caribbean ship that had required passengers 16 and older to be fully vaccinated against COVID-19 and all passengers to receive a negative test before boarding. Last week, 27 people – 26 of whom were crew members – tested positive for COVID-19 on Carnival Cruise Line’s Carnival Vista ship. More than 99% of crew members were vaccinated on the ship and 96.5% of passengers were vaccinated, according to the Belize Tourism Board.
The maddening hospital price differences that you pay according to how you are insured
The New York Times gives us a look at why it is good for patients that hospitals are required to publish their prices for common treatments and procedures. Hospitals fought that rule, which took effect today. Some make it difficult to find the prices. But, when you do, you find what the Times found: “In many cases, insured patients are getting prices that are higher than they would if they pretended to have no coverage at all.”
The Times points out, “This secrecy has allowed hospitals to tell patients that they are getting “steep” discounts, while still charging them many times what a public program like Medicare is willing to pay. And it has left insurers with little incentive to negotiate well. The peculiar economics of health insurance also help keep prices high.”
If Congress wants to investigate something useful that affects everyone — including you, me and our employers — this is a good place to spend some time and energy.
The times in which we live in one post
You saw that sentence in the cutline, right? First class airline passengers, who I assume are less rowdy, still get drinks.
I now have a collection of drink tickets from airlines that do not serve alcohol but plan to next year. I don’t drink, but I certainly understand why a person might these days.
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