Today, W.S. in Florida asks:
I got my first Pfizer vaccine in January. Is it too late to get the second injection now, more than two months later? What should I do?
The second dose of Pfizer-BioNTech’s vaccine should ideally be given three weeks after the first. (Moderna’s second dose is meant to be given four weeks after the first, while the Johnson & Johnson/Janssen shot is delivered in a single dose.) But, well, sometimes life gets in the way. So what happens if you don’t make it to that second appointment?
Schedule another one as soon as you can, says Dr. Adam Ratner, a pediatric infectious disease doctor at NYU Langone Health and a vaccine researcher.
While a three- or four-week gap between shots is ideal, the U.S. Centers for Disease Control and Prevention (CDC) says you can get your second shot within 42 days of the first one and still mount a full immune response. “Beyond that, we start to operate in an area where there’s simply less data,” Ratner says.
That doesn’t mean your second shot will be ineffective if it’s given more than six weeks after the first. It only means that studies have not specifically measured how much protection the two-dose vaccines offer when the shots are given more than 42 days apart. Still, the CDC says you don’t have to start over if you can’t get a second vaccine within 42 days. Countries including the U.K. are even purposely delaying second shots so they can get first doses out to more people, and some experts in the U.S. advocate for the same policy.
Ratner says if he were in your shoes, he wouldn’t worry too much. “I would say get the second dose now and consider yourself fully vaccinated,” he says. Just make sure you get a second dose of the same vaccine, since the CDC does not recommend mixing and matching with different shots.
It may be tempting to just stick with the one dose you’ve got—after all, one recent study showed that a single dose of the vaccine was about 80% effective at preventing COVID-19 infections, compared to 90% protection after two doses. But “it is somewhat of a tenuous 80%,” National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said at a recent press briefing. “When you leave it at one dose, the question is, ‘How long does it last?’”
To get the vaccine’s full benefits, and to make sure they last as long as possible, you’ll need a second shot.
CDC director walks tightrope on pandemic messaging
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky finds herself in a delicate position as she seeks to balance the optimism of increasing vaccinations with the reality that the U.S. is still very much in the grip of a deadly pandemic.
Walensky started the CDC job with a reputation as a savvy communicator, tasked with salvaging the reputation of an agency that took a beating under the Trump administration.
“When I first started at CDC about two months ago, I made a promise to you: I would tell you the truth, even if it was not the news we wanted to hear,” Walensky told reporters recently.
Walensky’s expertise is in HIV research, like her predecessor Robert Redfield, and before being appointed to lead the CDC, she was head of infectious diseases at Massachusetts General Hospital.
While former colleagues say Walensky is the perfect fit for the CDC post, her skills are now being put to the test as she faces criticism for being both too negative and too hopeful.
“She is quite a compelling and clear communicator, but it’s a challenging set of messages to try and get out there,” said Chris Beyrer, a professor of epidemiology at Johns Hopkins Bloomberg School of Public Health.
Public health messaging during a global pandemic is complicated enough, but experts say this particular moment is especially difficult.
After weeks of decline and then stagnation, the rate of coronavirus infections has once again started to climb across much of the country. Cases are up about 12 percent nationally compared with the previous week, averaging around 62,000 cases per day, according to the CDC.
At the same time, nearly 100 million Americans have received at least one dose of a coronavirus vaccine. Many states are expanding vaccine eligibility, in some instances to all adults, and federal health officials say there will be enough supply for everyone to be vaccinated by the end of May.
Walensky tried to emphasize both aspects this week when she issued an emotional appeal to the public.
“We have so much to look forward to, so much promise and potential of where we are, and so much reason for hope. But right now I’m scared,” Walensky said, adding that she had a “sense of impending doom” if people continued to ignore public health precautions.
Yet almost in the next breath, she talked about a “tremendously encouraging” new study showing that vaccinated people were 90 percent protected from infection, meaning they pose an extremely low risk of spreading the virus.
While that may come across as mixed messaging, experts say it accurately reflects not only where things stand right now but also how the country has been reacting to the virus for the past year.
“Whiplash is a true reflection of how we’re all experiencing the epidemic and the response to it. So I’d rather she be honest about that and others be honest about that than give people something that they want … to make them feel better,” said Judith Auerbach, a professor in the University of California San Francisco School of Medicine.
Auerbach, who previously worked with Walensky on HIV research, praised the director’s openness, which she said had been missing from agency leadership during the Trump administration.
“She’s being really honest about her own emotions. That’s hard for a fed to do and get away with,” Auerbach said. “The science that says we all still need to be, in fact, quite scared because we’re in this race between the vaccines … versus the emergence of these variants, and she felt it at a visceral level, and she conveyed that in a way that I thought was quite telling.”
Glen Nowak, director of the Center for Health and Risk Communication at the University of Georgia and a former CDC media relations director, said Walensky’s candor helps establish credibility.
“She has embraced the fact that credibility comes from being transparent and honest and genuine about your fears and your concerns,” Nowak said.
The CDC declined to make Walensky available for an interview, but in a statement to The Hill, an agency spokesman said every communication reflects the latest science and epidemiology.
“At times, moments must balance hope that we will move out of the pandemic with the reality that we are not out of it yet,” the spokesman said.
“We acknowledge the challenge of conveying such hope and promise that vaccines offer with the reality that cases and deaths are rising. While we are sending the critical message that people cannot and should not let up on their prevention measures, we do remain very optimistic about what the future of a fully vaccinated public will offer,” the spokesman added.
On Friday, Walensky again came under criticism for her messaging. In updated guidance, the CDC said it is safe for people who have been fully vaccinated to travel.
But Walensky struck a cautionary tone by saying the CDC still recommends anyone, vaccinated or not, avoid nonessential travel because infection numbers are so high.
“We know that right now we have a surging number of cases,” Walensky said during a White House briefing. “I would advocate against general travel overall. Our guidance is silent on recommending or not recommending fully vaccinated people travel. Our guidance speaks to the safety of doing so.”
Nowak said part of what makes public health messaging so difficult is the fact that science doesn’t always deal in absolutes and that the public overall doesn’t do well with nuance.
“Often people don’t want to listen to the nuance; they want advice and guidance to be stable. They get frustrated with the changes or when it seems to be contradictory. They also get frustrated if it doesn’t match their everyday living experiences,” Nowak said.
With the travel guidance, Walensky attempted to spell out the balance she was trying to strike and asked the public for patience and understanding.
“I want to acknowledge today that providing guidance in the midst of a changing pandemic and its changing science is complex,” Walensky said.
“The science shows us that getting fully vaccinated allows you to do more things safely, and it’s important for us to provide that guidance, even in the context of rising cases. At the same time, we must balance the science with the fact that most Americans are not yet fully vaccinated, which is likely contributing to our rising cases,” she said.
Jen Kates, director for global health and HIV policy at the Kaiser Family Foundation, who has known Walensky for decades, said she thinks the CDC director is aware that she can’t escape criticism, especially when so many people have pandemic fatigue.
If the CDC is too strict and refuses to endorse relatively normal behavior, especially after people get vaccinated, it could risk others refusing to get the shot, Kates said.
But if the agency paints too rosy a picture, more people could act like the pandemic is over and risk further spread of the virus.
“It behooves public officials to always be cognizant that their words are being listened to and can be taken out of context or may be hard for people to grasp,” Kates said. “So I think Dr. Walensky is a great communicator, but that doesn’t mean that this is always easy to do and the balance is always straightforward.”
Vaccine passports could become available soon to help people resume their lives — but they face numerous scientific, social and political barriers to being accepted.
The big picture: Reliable and accessible proof of vaccine-induced protection from the novel coronavirus could speed international travel and economic reopening, but obstacles to its wide-scale adoption are so great it may never fully arrive.
Driving the news: The secure digital identity app CLEAR and CommonPass, a health app that lets users access vaccination records and COVID-19 test results, will be working together to offer a vaccine passport service, my Axios colleague Erica Pandey reports.
Yes, but: There are numerous health, ethical and operational questions that need to be resolved before vaccine passports could become an effective part of daily life.
Health: Medical experts still don’t fully know how effective vaccinations — or exposure to the virus — are at preventing onward transmission of COVID-19.
Ethical: The most obvious use case for vaccine passports is for international travel, which has been crippled by onerous quarantine restrictions. But such a system risks locking out billions of people who are unable or unwilling to get the vaccine.
Operational: Passports for international travel are regulated by governments and have decades of history behind them, but there’s no such unified system for vaccine passports, which are being introduced by governments and businesses with different standards, making them a target for fraud.
Be smart: None of these obstacles are insurmountable on their own. But as we saw with the failures of digital contact tracing, just because a technological solution exists doesn’t mean it will be effective or adopted by the public.
The bottom line: Some form of vaccine visas will likely be introduced for international travel, but it seems unlikely they’ll become a passport to resuming normal life.
https://mailchi.mp/3e9af44fcab8/the-weekly-gist-march-26-2021?e=d1e747d2d8
It was a relatively quiet week on the COVID front—so quiet that President Biden held his first White House press conference last week and wasn’t asked a single question about the pandemic, which continues to be a race between vaccinations and virus variants.
Not that nothing happened this week: it was a rocky week for AstraZeneca, which was hoping to change the narrative over its vaccine, which has stumbled in its rollout in Europe, by reporting positive results from US trials.
After a press release announcing that the vaccine was found to be 79 percent effective against symptomatic COVID, an independent review board called the results into question, pointing out that the report was based on data that had not been fully updated. That earned a swift and unusual rebuke from the National Institutes of Health (NIH), forcing the company to correct its findings—to 76 percent.
A relatively minor difference, but the dust-up served to further undermine confidence in the company’s COVID jab, especially troubling in Europe where hesitancy and distribution have been a vexing problem, and concerns about blood clots associated with the AstraZeneca shot caused several countries to pause inoculations. Given the supply of already-approved vaccines from other manufacturers in the US, it’s not clear that the AstraZeneca shot will play a big role here, but it is critical in other parts of the world, especially as part of the global COVAX initiative targeted at developing countries, since the vaccine can be stored at normal refrigerator temperatures.
The company’s set-to with American regulators also highlighted another challenge that’s become common during the COVID pandemic: conducting scientific review by press release, as the global emergency has required the otherwise slow-moving research community to move at lightning pace.
Meanwhile, back at that relatively dull White House press conference, one piece of encouraging news: President Biden doubled his “first 100 days” goal for vaccinations to 200M shots, a goal that seems wholly achievable, given that 2.5M Americans are being vaccinated every day, on average.
Experts take pro-vaccine message to right-wing skeptics
Top public health experts and officials are developing new strategies to reach out to the conservatives most skeptical of or hesitant about receiving a coronavirus vaccine.
The efforts are targeting supporters of former President Trump, who have emerged as the most significant hurdle to widespread vaccination.
The officials and experts are making appearances on Fox News and Newsmax and taking part on panels with prominent conservative politicians to reach out to vaccine skeptics on the right.
And the public health experts are not taking an antagonistic approach either. They say many conservatives have legitimate questions about COVID-19 vaccinations that are worth listening to and answering.
“These are folks who really feel disrespected. They feel that COVID and the vaccines and the response has been politicized and weaponized, in their words,” said Tom Frieden, the former director of the Centers for Disease Control and Prevention under President Obama. “They feel deeply alienated from the government.”
Up to now, the main problem with increasing vaccinations has been one of supply and demand, but administration officials expect that to change shortly.
“We are approaching the point where we will have a sufficient supply of vaccines for everybody in the United States to have the chance to get immunized by the end of May,” Francis Collins, director of the National Institutes of Health (NIH), said in an interview with The Hill on Wednesday.
At that point, convincing skeptical conservatives to get a shot could mean the difference between the U.S. achieving herd immunity and resuming normal life or variants of COVID-19 getting second and third winds, leading to new lockdowns or restrictions on life.
As Collins puts it, “the hesitancy will begin to become the defining factor on whether we reach herd immunity or not.”
“I think that means this has to be the moment where we really pull into this conversation all of the trustworthy voices,” he added.
A recent CBS poll found a third of Republicans said they would not be vaccinated, compared to 10 percent of Democrats. A “PBS NewsHour” poll showed similar results: Nearly half of U.S. men who identify as Republicans said they have no plans to get vaccinated.
The underlying mistrust comes after a year in which Trump and his allies played down the severity of a virus that has killed more than half a million Americans already.
Circumstances have conspired to allow that skepticism to grow: The coronavirus arrived later in more rural, conservative enclaves than it did in liberal metropolitan areas like Seattle, New York and Detroit, giving some the sense that they had been locked out of the economy to protect against a virus that was not yet present in their community.
Julie Morita, executive vice president of the Robert Wood Johnson Foundation, who advised the Biden transition team on COVID-19 issues, said she has been surprised to see how political vaccine hesitancy has become.
In the past, Morita said, public health officials have focused on race and ethnicity. “We didn’t really look at politics or political affiliation,” she said.
Morita said her message remains the same, but that she has had to focus on where to deliver it. She recently co-wrote a Fox News op-ed answering some of the common questions about the available COVID-19 vaccines and urging people to get the shots when they’re available.
“Whether you’re a community of color, or whether you’re a conservative, these are the questions that people ask and want to have the answers to before they get vaccinated,” Morita said. “I don’t feel like that’s a shifted message as much as maybe we’re just able to get it into a more conservative news outlet.”
Convincing a group of people who did not vote for the president presents a challenge to a Democratic administration. So President Biden has been outsourcing the message.
Appearing on Hugh Hewitt’s radio show this week, Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases, said he doesn’t shy away from conservative outlets that may not be friendly.
“I say yes to a wide variety of requests. I’ve been on Fox multiple times, so I don’t shy away from that, no,” Fauci said.
Health officials are increasingly convinced that successful messaging is not going to come from politicians or government officials but from doctors, clergy and trusted community leaders.
Last month, Frieden participated in focus groups with vaccine-hesitant Republican voters led by veteran GOP pollster Frank Luntz.
The groups, first reported by The Washington Post, showed vaccine-hesitant conservatives were not swayed by Republican politicians like House Minority Leader Kevin McCarthy (Calif.) or former New Jersey Gov. Chris Christie — or even by Trump himself.
Instead, Frieden said, the message that moved the hesitant to the accepting hit closer to home: Their doctors took the vaccine when it was offered.
“You listen to the audience, you understand where they are and you address their concerns. And that’s the same thing we have to do for Trump voters who are reluctant to get vaccinated or African Americans or Latinx or vegans who don’t want to get vaccinated,” Frieden said.
Morita said she thinks the same efforts and resources that go into convincing communities of color should also be directed at conservatives.
“High-level government officials espousing the importance of vaccines and sharing their experiences with it is really important but it’s not sufficient,” Morita said.
Support for Trump and a distrust of the government is not the only reason conservatives might be reluctant to accept the vaccine. Many are concerned about how quickly the vaccines were developed.
Still others object on religious grounds, which is where Collins, the NIH director, comes in.
A devout Christian who is open about his faith, Collins has become an ambassador to the faith community. He spends hours a day talking to faith leaders, assuring them of the vaccine’s soundness and science.
Collins told The Hill he frames the decision to get vaccinated in religious terms.
“Is this a love your neighbor moment? Yes, it is,” Collins said. “And whatever faith you are, the Golden Rule seems to apply, and the Golden Rule would say, for your neighbor or for your family, for your neighbors down the street who may be vulnerable, this is something you can do for them.”
Wealthy nations — including the U.S., the U.K. and the EU — have vaccinated their citizens at a rate of one person per second over the last month, while most developing countries still haven’t administered a single shot, according to the People’s Vaccine Alliance.
Why it matters: As higher-income countries aim to achieve herd immunity in a matter of months, most of the world’s vulnerable people will remain unprotected.
The big picture: Even though more vaccines will arrive in developing nations soon, only 3% of people in those countries are likely to be vaccinated by mid-2021.
What we’re watching: Three dozen countries have bought several times the amount of vaccine that they’ll need to vaccinate their entire population.
Scientists at the Food and Drug Administration said Wednesday that the single-shot Covid-19 vaccine developed by Johnson & Johnson is effective and prevents hospitalizations from the disease.
Johnson & Johnson also revealed new, encouraging data showing the vaccine may do a better-than-expected job at protecting patients against new variants of the virus that causes disease. At the same time, FDA experts said the company’s study, results of which were originally made public in a Jan. 29 press release, includes insufficient information to draw conclusions on efficacy in people older than 75.
Documents from the FDA scientists, as well as separate documents from Johnson & Johnson, were released ahead of a Friday meeting of an FDA advisory panel in which outside experts will discuss and then vote on the risks and benefits of the new vaccine. The panel, known as the Vaccines and Related Biological Products Advisory Committee, makes recommendations to the FDA; the agency is not required to follow them, but it generally does.
The J&J vaccine is the first vaccine to show efficacy given as a single dose. It also does not need to be kept frozen when being shipped, as the vaccines developed by Moderna and the team of Pfizer and BioNTech do. Both of those advantages could be profound when it comes to vaccinating as many people as possible, a key step in slowing the spread of SARS-CoV-2.
Overall in the study, the vaccine reduced cases of Covid-19 that were rated as moderate to severe by 66.1% when considering cases occurring at least 28 days after vaccination. There were 193 cases that occurred at least 28 days after vaccination in the placebo group and 66 in the vaccine group. As of Feb. 5, there were seven Covid-19 related deaths in the placebo group and none in the vaccine group.
FDA researchers conducted a new analysis of how frequently volunteers in the study were hospitalized for Covid. When researchers counted cases 28 days after vaccination, there were zero hospitalizations in the vaccine arm and 16 in the placebo arm. For the full analysis set starting with the first dose, there were six hospitalizations for those who received the vaccine and 42 for those who did not.
Johnson & Johnson and the National Institutes of Health initially announced interim results of a 44,325 study testing the vaccine’s efficacy on Jan. 29. At the time, they said the 66% efficacy varied by geography. The vaccine was 72% protective in the U.S., compared to 58% in South Africa, where a new variant of SARS-CoV-2 is circulating.
In new documents, Johnson & Johnson said that in South Africa, the vaccine reduced severe or critical Covid-19 by 81.7% starting 28 days after vaccination, but that efficacy against more moderate disease was 64%. But the company said that the vaccine efficacy was not affected by the high prevalence of another variant in Brazil.
Unexpected side effects occurred at the same rate overall among volunteers who received vaccine and placebo — about 0.5%. However, some rare conditions appeared more common with the vaccine. Blood clot-related conditions occurred in 15 volunteers who received the vaccine and 10 who received placebo. Tinnitus, a ringing in the ears, occurred in six volunteers who received the vaccine and none who received placebo. The FDA said it will recommend monitoring for thromboembolic events after an EUA is granted.
Expected side effects that are related to the vaccine’s effect were common. Nearly half of volunteers reported injection site pain, 38.9% reported headache, 38.2% fatigue, and 33% reported muscle aches.
Johnson & Johnson also conducted an analysis in 2,650 volunteers looking at whether those who received the vaccine were less likely to test positive for the SARS-CoV-2 virus, which causes Covid-19, without having symptoms. There were 50 such cases in the placebo group compared to 18 among those who received the vaccine, a 65.5% reduction.
The United States has purchased 100 million doses of the vaccine, with an option to buy another 200 million doses. The agreement, announced last August, netted J&J over $1 billion in a contract with the Biomedical Advanced Research and Development Authority and the Department of Defense.
That said, the company currently has a limited number of doses to contribute to the effort to step up the country’s vaccine rollout. It will be April before J&J begins to have substantial amounts of vaccine to feed into the distribution pipeline, Moncef Slaoui, former co-chair of Operation Warp Speed, said earlier this year.
However, the company and the NIH said the vaccine was 85% effective at preventing severe disease, with no differences seen across the eight countries included in the study.
J&J is also conducting a trial in the United States of a two-dose vaccine, with the doses given eight weeks apart.The results from that 30,000 person trial are not expected until sometime in May.
The FDA documents represent the first close look at the data released Jan. 29, and are the result of a three-week effort by FDA scientists to independently evaluate the data generated in the trial. Friday’s panel will provide a deeper look at what those data actually mean.
As both vaccinations and acquired immunity spread, life will likely settle into a new normal that will resemble pre-COVID-19 days— with some major twists.
The big picture: While hospitalizations and deaths are tamped down, the novel coronavirus should recede as a mortal threat to the world. But a lingering pool of unvaccinated people — and the virus’ own ability to mutate — will ensure SARS-CoV-2 keeps circulating at some level, meaning some precautions will be kept in place for years.
Driving the news: On Tuesday, Johnson & Johnson CEO Alex Gorsky told CNBC that people might well need a new coronavirus vaccine annually in the years ahead, much as they do now for the flu.
Be smart: That sounds like bad news — and indeed, it’s much less ideal than a world in which vaccination or infection conferred close to lifelong immunity and SARS-CoV-2 could be definitively conquered like smallpox.
Details: From studying what happened after new viruses emerged in the past, scientists predict SARS-CoV-2 will eventually become endemic, most likely in a seasonal pattern similar to the kind of coronaviruses that cause the common cold.
Yes, but: The existence of a stubborn pool of Americans who say they won’t get vaccinated — as well as the fact that it may take far longer for children, whom the vaccines have yet to be tested on, to get coverage — will give the virus longer legs than it would otherwise have.
What’s next: This means we can expect the K-shaped recovery that has marked the pandemic to continue, says Ben Pring, who leads Cognizant’s Center for the Future of Work.
The catch: That’s not all bad — the measures put in place to slow COVID-19 have stomped the flu and other seasonal respiratory viruses, and if we can hold onto some of those benefits in the future, we can save tens of thousands of lives and billions of dollars.
“If we go back to ‘normal,’ then we have failed.”
— Mark Sendak
What to watch: Whether the vaccine rollout can be adapted to reach hard to find and hard to persuade populations.
The bottom line: While SARS-CoV-2 has proven it can adapt to a changing environment, so can we. But we have to do so in a way that is fairer than our experience of the pandemic has been so far.
https://mailchi.mp/85f08f5211a4/the-weekly-gist-february-5-2021?e=d1e747d2d8
A family member in her 70s called with the great news that she received her first dose of the COVID vaccine this week. She mentioned that she was hoping to plan a vacation in the spring with a friend who had also been vaccinated, but her doctor told her it would still be safest to hold off booking travel for now: “I was surprised she wasn’t more positive about it. It’s the one thing I’ve been looking forward to for months, if I was lucky enough to get the shot.”
It’s not easy to find concrete expert guidance for what it is safe (or safer?) to do after receiving the COVID vaccine. Of course, patients need to wait a minimum of two weeks after receiving their second shot of the Pfizer or Moderna vaccines to develop full immunity.
But then what? Yes, we all need to continue to wear masks in public, since vaccines haven’t been proven to reduce or eliminate COVID transmission—and new viral variants up the risk of transmission. But should vaccinated individuals feel comfortable flying on a plane? Visiting family? Dining indoors? Finally going to the dentist?
It struck us that the tone of much of the available guidance speaks to public health implications, rather than individual decision-making. Take this tweet from CDC director Dr. Rochelle Walensky. A person over 65 asked her if she could drive to visit her grandchildren, whom she hasn’t seen for a year, two months after receiving her second shot. Walensky replied, “Even if you’ve been vaccinated, we still recommend against traveling until we have more data to suggest vaccination limits the spread of COVID-19.”
From a public health perspective, this may be correct, but for an individual, it falls flat. This senior has followed all the rules—if the vaccine doesn’t enable her to safely see her grandchild, what will? It’s easy to see how the expert guidance could be interpreted as “nothing will change, even after you’ve been vaccinated.”
Debates about masking showed us that in our individualistic society, public health messaging about slowing transmission and protecting others sadly failed to make many mask up.
The same goes for vaccines: most Americans are motivated to get their vaccine so that they personally don’t die, and so they can resume a more normal life, not by the altruistic desire to slow the spread of COVID in the community and achieve “herd immunity”.
In addition to focusing on continued risk, educating Americans on how the vaccinated can make smart decisions will motivate as many people as possible to get their shots.
HENRY KOTULA 