FDA scientists endorse J&J’s Covid vaccine, as new data shed light on efficacy


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 At the same time, FDA experts said the company’s study, results of which were originally made public in a Jan. 29 press release, includes insufficient information to draw conclusions on efficacy in people older than 75.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.

The pandemic’s coming new normal

Photo illustration of the Freedom from Want image by Norman Rockwell with all the participants of the dinner wearing surgical masks.

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.

  • Gorsky’s comments were one of the clearest signals that even as the number of vaccinated people rises, the mutability of SARS-CoV-2 means the virus will almost certainly be with us in some form for years to come.

Be smartThat 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.

  • With more contagious variants spreading rapidly, “the next 12 weeks are likely to be the darkest days of the pandemic,” says Michael Osterholm, the director of the University of Minnesota’s Center for Infectious Disease Research and Policy.
  • But the apparent effectiveness of the vaccines in preventing hospitalizations and death from COVID-19 — even in the face of new variants — points the way toward a milder future for the pandemic, albeit one that may be experienced very differently around the world.

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.

  • That’s nothing to sneeze at — literally, it will make us sneeze — but as immunity levels accumulate throughout the population, our experience of the virus will attenuate, and we’ll be highly unlikely to experience the severe death tolls and overloaded hospitals that marked much of the past year.

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.

  • “This will be with us forever,” says Osterholm. “That’s not even a debate at this point.”

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.

  • With the virus likely to remain a threat, even if a diminished one, “those who are more stuck in the analog world are really going to continue to struggle,” he says.
  • Health security will also become a more ingrained part of daily life and work, which means temperature checks, masks, frequent COVID-19 testing and even vaccine passports for travel are here to stay.

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 the inequalities seen in the early phase of the vaccine rollout persist, COVID-19 could become a disease of the poor and disadvantaged, argues Mark Sendak, the co-founder and scientific adviser for Greenlight Ready, a COVID-19 resilience system that grew out of Duke Health.
  • Sendak points to the example of HIV, a disease that is entirely controllable with drugs but continues to exert a disproportionate toll on Black Americans, who take pre-exposure prophylactic medicine at much lower rates.

“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 Biden administration announced yesterday that it will start delivering vaccines directly to community health centers next week in an effort to promote more equity in the vaccine distribution process.
  • As the administration rolls out new COVID-19 plans, it needs to “invest in the community health care personnel” who can ensure that no one is left behind, says Sendak.

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.

“I got the vaccine…now what can I do?”

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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.

Disparities may worsen as vaccine eligibility widens

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Early data on vaccine distribution by race and ethnicity show a mismatch between those population groups receiving the vaccine, and those that have been hardest hit by the pandemic. As the graphic above shows, Black and Hispanic Americans have thus far been vaccinated at considerably lower rates in many states compared to their share of population as a whole—and these disparities are likely to worsen as states shift focus to senior populations for priority access, moving away from prioritizing essential workers, who tend to be more racially diverse.

The White population skews older, which stands to widen disparities in the near-term. Another compounding issue: vaccine hesitancy.

A recent Morning Consult poll found that, despite an overall increase in overall vaccine willingness, Black Americans remain the most hesitant, with only 48 percent willing to get the vaccine.

Meanwhile, Black and Hispanic Americans continue to be disproportionately impacted by COVID, with hospitalization and death rates nearly three to four times greater than those of White Americans.

Hesitancy will become an increasingly urgent problem as larger swathes of the population become eligible for vaccination, especially given that communities of color tend to be younger, as shown above.

Turning the tide in the battle against the virus

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The national COVID indicators all continued to move in the right direction this week, with new cases down 16 percent, hospitalizations down 26 percent, and deaths (while still alarmingly high at more than 3,000 per day) down 6 percent from the week prior.

More good news: both nationally and globallythe number of people vaccinated against COVID now exceeds the total number of people infected with the virus, at least according to official statistics—the actual number of coronavirus infections is likely several times higher.

On the vaccine front, Johnson & Johnson filed with the Food and Drug Administration (FDA) for an Emergency Use Authorization for its single-dose COVID vaccine, which could become the third vaccine approved for use in the US following government review later this month. The J&J vaccine is reportedly 85 percent effective at preventing severe COVID disease, although it is less effective at preventing infection than the Pfizer and Moderna shots.

Elsewhere, TheLancet reported interim Phase III results for Russia’s Sputnik V vaccine trials, showing it to be 91 percent effective at preventing infection, and a new study found the Oxford-AstraZeneca vaccine to be 75 percent effective against the more-contagious UK virus variant.

Amid the positive vaccine news, the Biden administration moved to accelerate the vaccination campaigninvoking the Defense Production Act to boost production and initiating shipments directly to retail pharmacies. With the House and Senate starting the budget reconciliation process that could eventually lead to as much as $1.9T in stimulus funding, including billions more for vaccines and testing, it feels as though the tide may be finally turning in the battle against coronavirus.

While the key indicators are still worrisome—we’re only back to Thanksgiving-week levels of new cases—and emerging variants are cause for concern, it’s worth celebrating a week that brought more good news than bad.

Best to follow Dr. Fauci’s advice for this Super Bowl weekend, however: “Just lay low and cool it.”

How soon can we achieve immunity through vaccinations?

Over the weekend I realized that my son Henry, born in June 2019, has lived more than half of his life in the pandemic era. He’s too young to be cognizant of it, of course, but my wife and I are acutely conscious of the experiences his older brother had already enjoyed by the time he was Henry’s age, things that are impractical or impossible in the moment.

He’s not alone in that, of course. Most Americans are experiencing some ongoing deprivations because of the pandemic. (Most of those for whom the pandemic is not imposing unusual restrictions are, ironically, probably contributing to the pandemic’s extent and duration.) Just about everyone in the United States is eagerly scanning the horizon for signs of normalcy — as we have been for months, occasionally spotting oases that too often turn out to be mirages.

So when will we return to some semblance of normal? It’s hard to say with certainty. The best tool we have to reach that point, though, is the broad deployment of the vaccines approved for emergency use by the government. But even the existence of those vaccines can’t completely answer the question.

For example, the rate at which the vaccines are deployed makes a massive difference. A pace of 2 million shots per day as opposed to 1 million seems like a subtle distinction but, obviously, means achieving immunity for recipients twice as fast.

What level of immunity is necessary is a question of its own. Do we need 70 percent of the country to have been immunized? Or, as infectious-disease expert Anthony S. Fauci has recently said, is the figure closer to 80 or 85 percent?

When doing this calculation, do you include the 26 million Americans who have already had coronavirus infections? What about young people? The vaccine trials included only those age 16 and over. Those younger have constituted about a 10th of the total infections. And what vaccine are we talking about? The Pfizer and Moderna iterations require two shots; the vaccine from Johnson & Johnson requires only one.

All of these factors affect how we can figure out when the country might hit the herd-immunity mark. If we assume that young people will be included among those needed to be vaccinated — a complicated question on its own — the calculator below will allow you to figure out when immunity might be achieved at various immunization rates.

At this rate, the country would reach 70 percent herd immunity through vaccinations by Nov. 10

How we calculate this:
There are about 330 million Americans, meaning that we need 231 million to be resistant to the virus to hit 70 percent immunity. We can take out the 5.8 million Americans who’ve already been vaccinated. That leaves 211.3 million people to be vaccinated.

From there the math is straightforward: doing two-shot vaccinations at a rate of 1.5 million shots per day means it will take 282 days to complete the job.

Bear in mind that sliding the little bar to determine how quickly shots are administered is far easier than actually scaling up the infrastructure to do so. President Biden’s original target for daily vaccinations was 1 million; he recently increased it to 1.5 million. At that rate, we’re still months from resolution. But because administering the vaccine is more complicated and requires more tracking than vaccinations such as that for the seasonal flu, it’s necessarily trickier to scale up.

At this point, the more urgent concern is the efficacy of the vaccine against any variants of the virus that might emerge. Manufacturers have already noted that the vaccine works less well against a virus variant first identified in South Africa, though the vaccines are still broadly effective, particularly at protecting the recipient from severe illness or death after infection.

Well, that and the fact that a fifth of Americans said in a recent Kaiser Family Foundation poll that they won’t get the vaccine or would do so only if it was required. Happily, more Americans are now saying they’re eager to get a vaccine.

The faster we get people immunized, the better we protect against the emergence of new mutations that prove less able to be controlled by the vaccines. The faster we get shots in arms, as the phrasing has it, the faster we get back to normal.

Which would be nice for all of us, including my 1-year-old.

Two lawmakers test positive for coronavirus, one after receiving both doses of vaccine

Politics - The Washington Post

Two members of Congress from Massachusetts have tested positive for the coronavirus, one after receiving both doses of the vaccine, a reminder that people can still be vulnerable to infection after being vaccinated, particularly in the two weeks after receiving the second dose.

Rep. Stephen F. Lynch (D-Mass.) tested positive for the virus on Friday afternoon after a staff member in his Boston office tested positive earlier in the week, his spokeswoman Molly Rose Tarpey said.

Lynch received a second dose of the Pfizer-BioNTech vaccine before the inauguration of President Biden on Jan. 20, but his office declined to specify the date it was administered. Lynch had tested negative for the virus before attending the inaugural ceremonies, Tarpey said.

“While Mr. Lynch remains asymptomatic and feels fine, he will self-quarantine and will vote by proxy in Congress during the coming week,” she said.

Tarpey added that Lynch “has followed CDC guidelines and continues to do so since he received the vaccine.”

Another Democrat from Massachusetts, Rep. Lori Trahan, announced Thursday that she had tested positive for the virus and was asymptomatic. Trahan, whose staff members have been working remotely, also said she planned to vote by proxy next week.

“I encourage everyone to continue taking this virus seriously and to follow the science and data-driven guidance to wear a mask, maintain a safe social distance from others, avoid large gatherings and stay home whenever possible,” Trahan said.

Trahan received her first shot of one of the vaccines last week, spokeswoman Francis Grubar told The Washington Post.

Occasional cases of people testing positive after receiving one or both doses are not unexpected, medical experts say. Clinical trial data published by Pfizer show that the vaccine is about 52 percent effective at preventing illness after the first shot, compared to 95 percent effectiveness seven days after the second dose.

A small number of patients can still become mildly sick even after they are fully vaccinated. But only one of the roughly 20,000 people who received both doses in the clinical trial developed severe covid-19, suggesting the vaccine is powerful protection against the most dangerous cases of the disease.

Members of Congress began getting vaccinated as early as Dec. 18, but Lynch at the time said he was “waiting for the vaccine to be first offered to health care personnel, first responders and vulnerable seniors” in his district, the Boston Herald reported. It is unclear when Lynch ultimately received his first dose of the vaccine; he would have received the second dose of the Pfizer-BioNTech vaccine about three to four weeks after the first.

Public health experts have emphasized that it usually takes one week after the second dose of the Pfizer-BioNTech vaccine to reach 95 percent efficacy and two weeks after the second dose of the Moderna vaccine to reach 94 percent efficacy.

“There’s no vaccine that I know that protects you the same day you get it,” Onyema Ogbuagu, the principal investigator for Pfizer’s vaccine trial at Yale University, told The Post’s Allyson Chiu. “On a population level, 95% efficacy still translates to 5/100, or 50/1,000, or 500/10,000 vaccinated persons still being vulnerable to symptomatic disease and maybe even more having asymptomatic carriage.”

At least 23.2 million people in the United States have received one or both doses of the vaccine. The Centers for Disease Control and Prevention recommends that vaccinated people continue to wear masks, socially distance, avoid poorly ventilated spaces and wash their hands frequently to prevent the spread of the virus.

“We also don’t yet know whether getting a covid-19 vaccine will prevent you from spreading the virus that causes covid-19 to other people, even if you don’t get sick yourself,” CDC guidelines state. “While experts learn more about the protection that covid-19 vaccines provide under real-life conditions, it will be important for everyone to continue using all the tools available to help stop this pandemic.”

Mask-wearing in particular has become politicized, including in the hallways of Congress. After the Jan. 6 siege at the Capitol, several Democrats said they feared they had been exposed to the virus after sheltering with Republican lawmakers who refused to wear masks. In the following, at least three lawmakers tested positive for the virus.

On Friday, Rep. Cori Bush (D-Mo.) accused Rep. Marjorie Taylor Greene (R-Ga.) of berating her in the hallways after she told Greene to put on a mask. The incident, coupled with other hostile rhetoric and Greene’s refusal to abide by rules and protocols put in place because of the pandemic, prompted Bush to decide to move her office away from Greene’s for safety reasons, the Missouri lawmaker said.

The good news from J&J

Johnson & Johnson Covid vaccine: Analysts are cautiously optimistic

The Johnson & Johnson coronavirus vaccine prevented 100% of hospitalizations and deaths in clinical trials, the company said today.

Why it matters: The single-dose vaccine could speed up the vaccinations of America’s vulnerable populations, as new variants spread.

By the numbers:

  • Overall: 66% effective in preventing moderate to severe COVID in nearly 44,000 participants in Phase 3 trials across eight countries.
  • In the U.S.: 72% effective.
  • In South Africa, home of a more aggressive variant: 57% effective.

What they’re saying:

  • Former CDC director Tom Frieden on the Axios Re:Cap podcast: “It has a lot of advantages, easier to store, easier to make.”
  • Former FDA commissioner Scott Gottlieb: “The J&J vaccine turns in a fantastic result. We now have three highly effective vaccines. This vaccine showed sustained (and increasing!) immune protection over time, perhaps from a robust early induction of memory immune cells (CD4 and CD8).”

What’s next: J&J is expected to apply for an emergency use authorization next week, the N.Y. Times reports.

  • “Federal regulators are also still waiting on data from Johnson & Johnson’s new manufacturing facility in Baltimore that prove it can mass-produce the vaccine. The company is counting on that factory to help reach its contractual pledge to the federal government of 100 million doses by the end of June.”