Category: COVID-19

Johnson & Johnson’s long-awaited vaccine appears to protect against COVID-19 with just one shot – not as strong as some two-shot rivals but still potentially helpful for a world in dire need of more doses.

J&J said Friday that in the U.S. and seven other countries, the single-shot vaccine was 66% effective overall at preventing moderate to severe illness, and much more protective — 85% — against the most serious symptoms.

There was some geographic variation. The vaccine worked better in the U.S. — 72% effective against moderate to severe COVID-19 – compared to 57% in South Africa, where it was up against an easier-to-spread mutated virus.

“Gambling on one dose was certainly worthwhile,” Dr. Mathai Mammen, global research chief for J&J’s Janssen Pharmaceutical unit, told The Associated Press.

With vaccinations off to a rocky start globally, experts had been counting on a one-dose vaccine that would stretch scarce supplies and avoid the logistics nightmare of getting people to return for boosters.

But with some other competing vaccines shown to be 95% effective after two doses, at question is whether somewhat less protection is an acceptable tradeoff to get more shots in arms quickly.

“Frankly, simple is beautiful,” said Dr. Matt Hepburn of Operation Warp Speed, the U.S. government’s vaccine initiative.

The company said within a week, it will file an application for emergency use in the U.S., and then abroad. It expects to supply 100 million doses to the U.S. by June — and a billion doses globally by the end of the year. J&J wouldn’t say exactly how much could be ready to ship as soon as U.S. authorities give the green light.

These are preliminary findings from a study of 44,000 volunteers that isn’t completed yet. Researchers tracked illnesses starting 28 days after vaccination – about the time when, if participants were getting a two-dose variety instead, they would have needed another shot.

After day 28, no one who got vaccinated needed hospitalization or died regardless of whether they were exposed to “regular COVID or these particularly nasty variants,” Mammen said. When the vaccinated did become infected, they had a milder illness.

Defeating the scourge that has killed more than 2 million people worldwide will require vaccinating billions, and the shots being rolled out in different countries so far all require two doses a few weeks apart for full protection. Early data is mixed on exactly how well all the different kinds work, but shots made by Pfizer and Moderna appear to be about 95% protective after the second dose.

That makes for a dilemma: Wouldn’t people given a choice want a vaccine found to offer much more protection?

J&J’s Mammen said direct comparisons are difficult because the Pfizer and Moderna vaccines weren’t tested when the pandemic was so severe, with record levels of hospitalizations and deaths plus mutant versions of the virus sweeping some countries.

Dr. Anthony Fauci, the top U.S. infectious disease official, called that a messaging challenge — because the priority is to protect people from hospitalization and death, which J&J’s vaccine appears to do. Especially in places where it’s hard to get people to return for their second dose, the one-dose version could play a key role.

Maybe more important is “a wake-up call” from the study that mutating viruses can challenge vaccines. And the best way to prevent more mutations is “by vaccinating as many people as you possibly can,” Fauci said.

All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spikey protein that coats it. But they’re made in very different ways.

J&J’s shot uses a cold virus like a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to prime the immune system in case the real virus comes along. It’s the same technology the company used in making a successful Ebola vaccine.

Rival AstraZeneca makes a similar cold virus vaccine that requires two doses. Both the AstraZeneca and J&J vaccines can be stored in a refrigerator, making them easier to ship and to use in developing countries than the frozen kind made by Pfizer and Moderna.

It’s not clear exactly how well the AstraZeneca version, being used in Britain and several other countries, works. Tests in Britain, South Africa and Brazil suggested two doses are about 70% effective although there are questions about how much protection older adults get. An ongoing U.S. study may provide more information.

J&J said its vaccine works consistently in a broad range of people: A third of participants were over age 60, and more than 40% had other illnesses putting them at risk of severe COVID-19, including obesity, diabetes and HIV.

J&J said the vaccine is safe, with reactions similar to other COVID-19 shots such as fever that occur when the immune system is revved up.

While it released few details, the company said there were no serious allergic reactions. But occasionally other COVID-19 vaccines trigger such reactions, which can be reversed if promptly treated – and authorities have warned people to be on the lookout regardless of which type of vaccine is used.

J&J had hedged its bets with a study of a two-dose version of its vaccine, which is still underway.

Friday’s interim results come on the heels of another vaccine in final testing. Novavax reported this week that its vaccine appears 89% effective in a U.K. study and that it also seems to work — though not as well — against new mutated versions of the virus circulating in Britain and South Africa. A larger study in the U.S. and Mexico is still enrolling volunteers.

Wall Street appeared dissatisfied with J&J’s results, with shares dropping 4.2% in early trading, a rare big drop for the world’s biggest maker of health care products. Shares were down $4.07, or 2.4%, at $165.09 in mid-morning trading.

In contrast, tiny Novavax saw shares skyrocket, jumping 71% to $229.72 in mid-morning trading.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

The race against the virus that causes COVID-19 has taken a new turn: Mutations are rapidly popping up, and the longer it takes to vaccinate people, the more likely it is that a variant that can elude current tests, treatments and vaccines could emerge.

The coronavirus is becoming more genetically diverse, and health officials say the high rate of new cases is the main reason. Each new infection gives the virus a chance to mutate as it makes copies of itself, threatening to undo the progress made so far to control the pandemic.

On Friday, the World Health Organization urged more effort to detect new variants. The U.S. Centers for Disease Control and Prevention said a new version first identified in the United Kingdom may become dominant in the U.S. by March. Although it doesn’t cause more severe illness, it will lead to more hospitalizations and deaths just because it spreads much more easily, said the CDC, warning of “a new phase of exponential growth.”

“We’re taking it really very seriously,” Dr. Anthony Fauci, the U.S. government’s top infectious disease expert, said Sunday on NBC’s “Meet the Press.”

“We need to do everything we can now … to get transmission as low as we possibly can,” said Harvard University’s Dr. Michael Mina. “The best way to prevent mutant strains from emerging is to slow transmission.”

So far, vaccines seem to remain effective, but there are signs that some of the new mutations may undermine tests for the virus and reduce the effectiveness of antibody drugs as treatments.

“We’re in a race against time” because the virus “may stumble upon a mutation” that makes it more dangerous, said Dr. Pardis Sabeti, an evolutionary biologist at the Broad Institute of MIT and Harvard.

Younger people may be less willing to wear masks, shun crowds and take other steps to avoid infection because the current strain doesn’t seem to make them very sick, but “in one mutational change, it might,” she warned. Sabeti documented a change in the Ebola virus during the 2014 outbreak that made it much worse.

MUTATIONS ON THE RISE

It’s normal for viruses to acquire small changes or mutations in their genetic alphabet as they reproduce. Ones that help the virus flourish give it a competitive advantage and thus crowd out other versions.

In March, just a couple months after the coronavirus was discovered in China, a mutation called D614G emerged that made it more likely to spread. It soon became the dominant version in the world.

Now, after months of relative calm, “we’ve started to see some striking evolution” of the virus, biologist Trevor Bedford of the Fred Hutchinson Cancer Research Center in Seattle wrote on Twitter last week. “The fact that we’ve observed three variants of concern emerge since September suggests that there are likely more to come.”

One was first identified in the United Kingdom and quickly became dominant in parts of England. It has now been reported in at least 30 countries, including the United States.

Soon afterward, South Africa and Brazil reported new variants. On Tuesday, researchers at Cedars-Sinai Medical Center in Los Angeles said yet another new variant has been found in one-third of COVID-19 cases in that city and may have fueled its recent surge in cases.

The main mutation in the version identified in Britain also turned up on a different version “that’s been circulating in Ohio … at least as far back as September,” said Dr. Dan Jones, a molecular pathologist at Ohio State University who announced that finding last week.

“The important finding here is that this is unlikely to be travel-related” and instead may reflect the virus acquiring similar mutations independently as more infections occur, Jones said.

That also suggests that travel restrictions might be ineffective, Mina said. Because the United States has so many cases, “we can breed our own variants that are just as bad or worse” as those in other countries, he said.

TREATMENT, VACCINE, REINFECTION RISKS

Some lab tests suggest the variants identified in South Africa and Brazil may be less susceptible to antibody drugs or convalescent plasma, antibody-rich blood from COVID-19 survivors — both of which help people fight off the virus.

Government scientists are “actively looking” into that possibility, Dr. Janet Woodcock of the U.S. Food and Drug Administration told reporters Thursday. The government is encouraging development of multi-antibody treatments rather than single-antibody drugs to have more ways to target the virus in case one proves ineffective, she said.

Current vaccines induce broad enough immune responses that they should remain effective, many scientists say. Enough genetic change eventually may require tweaking the vaccine formula, but “it’s probably going to be on the order of years if we use the vaccine well rather than months,” Dr. Andrew Pavia of the University of Utah said Thursday on a webcast hosted by the Infectious Diseases Society of America.

Health officials also worry that if the virus changes enough, people might get COVID-19 a second time. Reinfection currently is rare, but Brazil already confirmed a case in someone with a new variant who had been sickened with a previous version several months earlier.

WHAT TO DO

“We’re seeing a lot of variants, viral diversity, because there’s a lot of virus out there,” and reducing new infections is the best way to curb it, said Dr. Adam Lauring, an infectious diseases expert at the University of Michigan in Ann Arbor.

Loyce Pace, who heads the nonprofit Global Health Council and is a member of President-elect Joe Biden’s COVID-19 advisory board, said the same precautions scientists have been advising all along “still work and they still matter.”

“We still want people to be masking up,” she said Thursday on a webcast hosted by the Johns Hopkins Bloomberg School of Public Health.

“We still need people to limit congregating with people outside their household. We still need people to be washing their hands and really being vigilant about those public health practices, especially as these variants emerge.”

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AP Medical Writer Carla K. Johnson contributed reporting.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

ATLANTA (AP) — The coronavirus vaccines have been rolled out unevenly across the U.S., but four states in the Deep South have had particularly dismal inoculation rates that have alarmed health experts and frustrated residents.

In Alabama, Georgia, Mississippi and South Carolina, less than 2% of the population had received its first dose of a vaccine at the start of the week, according to data from the states and the U.S. Centers for Disease Control and Prevention.

As in other parts of the country, states in the South face a number of challenges: limited vaccine supplies, health care workers who refuse to get inoculated and bureaucratic systems that are not equipped to schedule the huge number of appointments being sought.

But other states have still managed — at their best — to get the vaccines into the arms of more than 5% of their populations.

Though it’s not clear why the Deep South is falling behind, public health researchers note that it has typically lagged in funding public health and addressing disparities in care for its big rural population.

“When you combine a large percentage of rural residents who tend to be the hard-to-reach populations and have lower numbers of providers with trying to build a vaccine infrastructure on the fly, that’s just a recipe for a not-so-great response,” said Sarah McCool, a professor in public health at Georgia State University.

In Georgia, the state’s rural health system has been decimated in recent years, with nine hospital closures since 2008, including two last year. Local health departments have become the primary vaccine providers in some locations, as officials work to add sites where doses can be administered.

“If we’re the only game in town, this process is going to take a long time,” Lawton Davis, director of a large public health district that includes Savannah, said at a news conference on Monday.

The district had to stop taking appointments in the face of an onslaught of requests after Georgia opened up the vaccine to people over 65. Other health districts in the state saw their websites crash.

Alabama and Mississippi have also been hit hard by rural hospital closures. Seven hospitals have shut down in Alabama since 2009 and six in Mississippi since 2005, according to researchers at the University of North Carolina’s Sheps Center. Alabama, Georgia and Mississippi ranked in the bottom five of U.S. states in their access to health care, according to a 2020 report from a not-for-profit foundation connected to insurance giant UnitedHealth.

But overall, experts say it’s too early in the vaccine rollout to draw conclusions about the region’s shortcomings, and they can’t easily be attributed to a particular factor or trend.

“We’re sort of building this plane as we’re flying, and there are going to be missteps along the way,” said Amber Schmidtke, a microbiologist who has been following vaccine dissemination in the South.

Officials in the individual states have cited a number of challenges, but have also acknowledged shortcomings.

“We have too many vaccines distributed that are not in arms yet,” said Mississippi Gov. Tate Reeves, who noted that some hospitals in the state are not using their vaccine doses. He said that practice “has to stop.”

Georgia Gov. Brian Kemp cited a similar challenge and warned providers holding on to vaccines that the state would take their unused doses even if that required “firing up” his pickup truck and doing it himself.

But in South Carolina, hospital officials say it is the state that has moved too slowly to expand access to the vaccinations, leaving them with unused doses. The state recently did offer the vaccine to those 70 and older.

Mississippi’s Reeves said one of the biggest weaknesses in the state’s vaccination system is the federal partnership with CVS and Walgreens to administer vaccinations in long-term care facilities. The pharmacy chains have been slow in hiring enough people to do the work in Mississippi, the governor said.

CVS Health said in a statement that it has “the appropriate resources to finish the job” at long-term care facilities. Walgreens did not respond to an email.

During an online forum hosted by Jackson State University in Mississippi on Thursday, U.S. Surgeon General Jerome Adams, who is Black, noted the reluctance of many African Americans to be vaccinated. He cited a general mistrust of medical systems stemming back to a now-defunct government study that started in the 1930s and left Black men untreated for syphilis for decades.

So far, only 15% of COVID-19 vaccinations in Mississippi have gone to Black people, who make up about 38% of the population, state health officer Dr. Thomas Dobbs said during the forum.

Officials in all four states also said some health care workers — among the first groups eligible for a vaccine — are choosing not to get inoculated. And some stressed that states were dealing with limited supplies and high demand and implored people to be patient.

“Yes, the phone lines will be busy. Yes, the websites will certainly crash,” Kemp said Tuesday. “There are simply vastly more Georgians that want the vaccine than can get it today.”

Mississippi officials said the state’s website and telephone hotline were overwhelmed after the governor announced Tuesday that vaccinations were available to people 65 or older or people who have underlying medical conditions.

Liz Cleveland, a 67-year-old retired state employee who lives in Jackson, waited hours on the website using her cellphone, computer and tablet only to encounter unknown errors.

“It’s like gambling. You may hit or you may bust,” Cleveland said.

About 2 a.m. Wednesday, she was finally able to book appointments for herself and her husband next week in Hattiesburg, which is 90 miles (145 kilometers) away. Mississippi officials said Thursday that they will open an additional drive-thru site for vaccinations soon in the state’s largest county.

Alabama officials also have been inundated with requests for appointments since announcing the state will begin vaccinations for people over 75 next week. A state hotline received more than a million calls the first day it was open.

Celia O’Kelley of Tuscaloosa said she couldn’t get through to anyone to get an appointment for her 95-year-old mother.

“I am scared because Tuscaloosa is a hot spot,” she said.

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Associated Press writers Kim Chandler in Montgomery, Alabama; Emily Wagster Pettus in Jackson, Mississippi; and Michelle Liu in Columbia, South Carolina, contributed to this report.