GOP Gov. Brian Kemp of Georgia on Thursday attempted to shift blame to President Joe Biden for the state’s low COVID-19 vaccination rate as the highly-infectious Delta variant continues to spread, according to The Associated Press.
While speaking to reporters, Kemp said that Biden needed to push harder to allow the Food and Drug Administration (FDA) to upgrade its emergency use authorization for the COVID-19 vaccines to full approval.
Kemp, who won his first race for governor in 2018, also stated that asking people to wear masks once again sends a “mixed message” and might cause people not to take the vaccine.
He encouraged Georgians to get vaccinated against COVID-19 and said he would look into other solutions if hospitals in the state became overwhelmed with patients.
“We know that the vaccines work,” Kemp said on Thursday. “I want to encourage people to get vaccinated if you’re comfortable doing that.”
Democratic state Sen. Michelle Au, an anesthesiologist, told The Associated Press that the state needed to do more to increase access to the vaccine and promote testing among residents who are unvaccinated.
“We aren’t trying hard enough,” Au told the news organization. “We like to blame the unvaccinated.”
On Thursday, Georgia posted over 4,800 positive COVID-19 tests, a high-point that was last reached in early February, when the vaccine wasn’t as readily available to the general public.
With the Delta variant spreading throughout Georgia, similar to the US as a whole, the number of COVID-19 hospitalizations across the state rose above 1,800.
COVID-19 infection rates have remained elevated in southeast Georgia.
Charlton County Administrator Hampton Raulerson told The Brunswick News that interest in the vaccines has not been robust.
“There’s a lot of distrust when it comes to the vaccine,” he said. “A lot of people thought (COVID-19) was going away.”
Kemp said that many people are reluctant to take the vaccine since it has still not been fully approved by the FDA.
“I’d love to see the Biden administration put an ‘Operation Warp Speed’ on moving away from the emergency use authorization,” he said on Thursday, referring to the Trump-era public-private vaccine development initiative that manufactured and distributed COVID-19 vaccines.
Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation, told The Washington Post on Friday that the agency is redeploying staff to accelerate their effort in fully approving the Pfizer-BioNTech vaccine.
“This will remove one more layer for the vaccine-hesitant,” Marks said.“If all this does is get five to 10 million more people vaccinations down south, that will save lives.”
The CDC earlier this week shifted their guidelines on mask-wearing, recommending face coverings for vaccinated people indoors in areas with high transmission of the virus.
Kemp said that the CDC’s new guidance didn’t inspire confidence.
“When you tell them they can get vaccinated and then take their mask off and then you turn around weeks later and reverse that, who’s gonna trust anybody, any politician, Republican, Democrat, or otherwise?” he said.
The Centers for Disease Control and Prevention released a study on Friday which suggests that fully vaccinated people can transmit the Delta variant of the coronavirus just as easily as the unvaccinated – a find that changes the calculus of what’s safe for vaccinated people to do, now that the Delta variant is responsible for more than 80% of US cases.
“Unlike with other variants, vaccinated people infected with Delta can transmit the virus,” CDC Director Rochelle Walensky said in a statement released alongside the new report.
The study is a big part of the reason why the CDC changed its guidance for vaccinated people on Tuesday, saying that where COVID-19 transmission is substantial or high, vaccinated people should mask up again indoors in public.
Delta was responsible for at least 90% of the cases in this outbreak, according to viral sequencing. It didn’t matter much which shots vaccinated people with Delta infections got, but the most common symptoms – including cough, headache, and sore throat – were mild.
An outbreak among a crowd that was 74% vaccinated
The study, released by the CDC on Friday, followed an outbreak that started in Barnstable County, an area of coastal Massachusetts that’s popular for summer vacations and parties, and attracts people from across the US.
According to the report, during the first half of July, multiple large events were held in an unnamed town there (local media coverage makes clear that it’s Provincetown.). The festivities included “densely packed indoor and outdoor events at venues that included bars, restaurants, guest houses, and rental homes.”
Among Massachusetts residents tied to the cluster and tracked by the state health department, 74% of the cases (346 infections) were in fully vaccinated people. The vast majority of the vaccinated infections were among men, with a median age of 42.
But the outbreak extends far beyond Massachusetts, with the total number of cases tied to the outbreak now estimated at more than 830 people, Provincetown Town Manager Alex Morse said on Facebook July 28.
Though the study demonstrates that vaccinated people are at greater risk of infection with Delta, the overwhelming majority of the breakthrough cases in the cluster have been mild, with symptoms including coughs, headaches, sore throats, muscle aches, and fevers. At least four vaccinated people were hospitalized, ranging from ages 20 to 70, but no deaths were reported. Two of the hospitalized patients had underlying conditions.
In other words, the vaccines are still achieving what they were designed to do: prevent severe infections and deaths.
Delta will ‘find any gap in our defenses’
Experts have been saying for weeks now that the Delta variant spreads both faster and more easily than other versions of the coronavirus, but this study provides some of the first clear evidence for why that’s the case.
Not only is the viral load of a person infected with Delta estimated to be about 1,000 times higher than with other versions of the virus, this study shows that a vaccinated person’s load is roughly equal to an unvaccinated person’s, meaning that vaccinated and unvaccinated people likely spread Delta equally well.
Andy Slavitt, a former senior adviser to President Joe Biden’s coronavirus response team, has called Delta “COVID on steroids,” while a leaked CDC slide presentation obtained by the Washington Post late Thursday said “the war has changed,” now that Delta is here.
The CDC slides also say Delta is more contagious than the common cold – on par with the chickenpox in its ability to spread.
“What the Delta variant will do is that it will find any gap in our defenses,” Hilary Babcock, medical director of infection prevention at Barnes-Jewish Hospital and St. Louis Children’s Hospital in Missouri previously told Insider.
“You have to be really more careful about it all the time.”
CDC Director Rochelle Walensky said Tuesday that “the Delta variant behaves uniquely differently” compared to other versions of the virus, and that vaccinated people “may be contagious and spread the virus to others.”
But the CDC isn’t recommending that everyone mask up again.
The agency’s new guidance is limited to places where COVID-19 transmission is deemed “substantial” or “high,” meaning that there are either more than 50 cases per 100,000 people in the area, over a seven-day period, or that the COVID-19 test positivity rate is higher than 5%.
“That’s why we are saying, in areas of substantial or high transmission, even if you are vaccinated, that we believe it’s important to wear a mask in those settings,” Walensky added.
“There are some people who are not able to be fully vaccinated, like children, and some people who are not able to be fully protected even though they are vaccinated, like immunocompromised people. So part of the reason for this guidance is to make sure that we can protect those [people].”
Mask guidelines, broken down by county
To find out if you’re in a place where transmission is substantial or high, you can use the CDC’s COVID Data Tracker, which drills down to the county level.
Much of the US is currently seeing “substantial” (orange), or “high” (red) rates of transmission, where masks are now advised indoors. In the few pockets of “moderate” (yellow) and “low” (blue) zones, fully vaccinated people can go mask-free, according to the CDC.
As an example, here’s what it looks like if you search “Dallas County, Texas” on the CDC’s map:
Transmission is high in Dallas County, meaning people should wear masks indoors in public, according to the CDC.
Only three US states are entirely in red – Florida, Arkansas, and Louisiana – but Missouri and Mississippi are almost there, with only a few scarce orange, yellow, and blue counties.
Even in New York City, where more than 65% of adults are now fully vaccinated, transmission is in the red or orange zone in all five boroughs, meaning all New Yorkers should mask up indoors in public.
“It is not a welcome piece of news that masking is going to be a part of people’s lives who have already been vaccinated,” Walensky said, stressing that medical experts, when shown the data on Delta infections in the US, “have universally said that this required action.”
This “could have been avoided with higher vaccination coverage,” she added.
A federal judge has blocked a request from the Centers for Disease Control and Prevention (CDC) to maintain COVID-19 restrictions on Florida cruise ships.
Florida District Judge Steven Merryday said in the court filing on Wednesday that his decision was “not about what health precautions against COVID-19 are necessary or helpful” but “about the use and misuse of governmental power.”
The legal battle started in April, when the state of Florida sued the CDC over its stringent rules for the cruise industry, called a Conditional Sailing Order (CSO), which the CDC introduced in October 2020. The CDC had “singled out” the industry, which “as a result, is on the brink of financial ruin,” the state said in the filing.
Under CSO rules added in May, cruise ships can only set sail normally when at least 95% of people on board, including the crew, are fully vaccinated. If not, ship operators must take volunteers on “test” cruises to show they can mitigate COVID-19 transmission.
Merryday said in Wednesday’s court order that the CDC’s “dark allusions” about the prospect of COVID-19 transmission on cruises ignored “state and local health authorities, the industry’s self-regulation, and the thorough and costly preparations and accommodations by all concerned to avoid ‘transmission’ and to confine and control the ‘transmission,’ if one occurs.”
The pandemic has hit the cruise industry hard since its outbreak last year. Cruise ship giant Carnival reported a $2.9 billion net loss in the third quarter of 2020, it said in an earnings filing.
The nation’s top doctors and nurses are near unanimous in their agreement that the COVID-19 vaccines authorized for use in the US are both effective and safe – even for young teenage boys who may, in rare cases, experience a type of heart inflammation called myocarditis, prompting chest pain after vaccination.
On Wednesday, an advisory group of experts independent to the CDC spent hours discussing and dissecting data on reports of myocarditis and pericarditis (heart swelling) in people under 29 years old who’ve been vaccinated against COVID-19 in the US.
The rate of such reports, while tiny, has been highest among young men, after their second dose of Pfizer or Moderna’s mRNA vaccines. 434 cases of myocarditis have been documented in males from 12-29 years of age, in the 21 days after their second shot. That’s a rate of about 0.004%, among more than 10 million vaccinated in that same age group nationwide.
But there’s also a link between COVID-19 infections and myocarditis, and it’s younger men who face the higher risk of death from COVID-19, according to data the advisory group reviewed.
At the end of the discussion, the CDC, the Department of Health and Human Services (HHS), and 15 more public health organizations released a joint statement, that said: “The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination.”
A rare event that resolves quickly
Even for these young men “this is still a rare event,” the CDC’s Dr. Tom Shimabukuro from the COVID-19 vaccine safety team said at the meeting, stressing that their cases typically resolve quickly.
“Most cases are mild, and individuals recover often on their own or with minimal treatment,” the joint statement also read. “In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”
The advisory group weighed the risks and benefits of vaccination to young men, and determined that benefits of vaccination clearly outweigh risks, even for males from 12-17 years old.
While there could be an additional 56 to 69 cases of myocarditis in this group, the advisors looked at forecast data that found vaccines could prevent 5,700 additional COVID-19 cases, 215 hospitalizations, 71 ICU admissions, and two deaths over 120 days.
What to do about second doses
The only group the CDC advised some caution for in administering second doses was young men who’ve had myocarditis after their first vaccine dose. They may want to defer a second dose, or discuss the situation with their doctor first.
For everyone else, medical professionals are stressing now’s the time to get vaccinated.
“With the troubling Delta variant increasingly circulating, and more readily impacting younger people, the risks of being unvaccinated are far greater than any rare side effects from the vaccines,” the joint statement continued.
“If you get COVID-19, you could get severely ill and be hospitalized or even die. Even if your infection is mild, you or your child could face long-term symptoms following COVID-19 infection such as neurological problems or diminished lung function.”
But King’s College epidemiologist Tim Spector says don’t be surprised if it shows up with different COVID-19 symptoms than those we’ve come to expect.
His latest research suggests that a headache and a runny nose are now two of the leading indicators of a COVID-19 infection across the UK, especially among the young and the partially vaccinated.
Spector’s research draws on daily illness data from more than a million people across the UK, who log into his ZOE app every day and report on how they’re feeling. ZOE’s research suggests about 19,000 people in the UK now catch COVID-19 every day. Most of them are young, and most are also not fully vaccinated.
“It’s evolved to be more infectious, which is what many viruses do,” Spector said, noting that the Delta variant may be roughly twice as infectious as its early predecessors, with each person who catches it transmitting to about six others.
“There’s no hard evidence yet that it’s more lethal or fatal, but because of that extra stickiness, it’s going to still keep breaking through,” he said.
According to ZOE’s latest data, from June 19, the COVID-19 case rate in the UK is now highest in the 20 to 29 age group.
“We’re seeing this mainly in young people who are unvaccinated, they are three quarters of the cases,” Spector said. “There’s hardly anyone who’s over 60 who’s getting it without a vaccine.”
Most of the people who test positive for COVID-19 in the UK are also weathering the traditional signs of a bad cold – headaches, runny noses, and sore throats – rather than the earlier tell-tale COVID-19 symptoms: shortness of breath or loss of taste.
It’s tough to know, though, if the Delta variant is truly becoming a milder disease, or if this is just how COVID-19 presents among the young, the healthy, and those with vaccine protection.
“Our hope is it’ll get milder,” Spector said. “So it will just become like a cold.”
The ‘most able and fastest and fittest’ variant
Disease watchers at the World Health Organization agree with Spector – yet another reason to get more of the world’s most vulnerable people vaccinated fast.
“This virus isn’t going to give up easily.” Spector said. “I don’t think we can be too complacent, particularly in areas of the US that have high non-vaccination rates.”
CDC Director Dr. Rochelle Walensky stressed in a White House COVID-19 briefing on Tuesday that “nearly every death” from COVID-19 in the US is now preventable. But time could be running out to ramp up protection, and the race with increasingly fitter variants is not over.
Dr. Ezekiel Emanuel is ready to step out and party – well, almost.
The chair of the department of medical ethics and health policy at the University of Pennsylvania hasn’t been to the theater in over a year and he says he’s “dying to go.” He’s also planning to travel to Switzerland this summer.
“How am I supposed to prove that I’ve been vaccinated?” he asks. “What I have now is a CDC cardboard piece of paper, right? It’s ridiculous.”
Emanuel says it shouldn’t be so hard for authorities to develop a reliable, relatively fraud-proof and secure driver’s license-style verification system for gauging COVID-19 immunity status. Ideally, such a system could replace the Centers for Disease Control and Prevention’s white vaccine cards, which are both easy to fabricate and too big to fit in standard wallets.
A vaccine license from the DMV?
Ezekiel, a former White House health policy advisor, imagines a world where “I could just have a QR code, and show it, and it would flash green,” offering permission to do all sorts of indoor activities in a secure, encrypted, and private way. It sounds like the kind of thing the DMV could pop onto a credit card-sized ID and print out.
“So, perhaps the DMV should have been in control of this?” I asked him, as I imagined the ensuing bureaucratic headaches.
“Look, you’re laughing, but … we know how to print those things,” he said.
“I want to know that everyone at work who’s going to be in a closed room with me is going to be vaccinated,” Emanuel said. “I’d love to go to the theater, but I also would love to go to the theater safely and knowing that everyone in the theater is vaccinated – you’re not allowed in the theater unless you’re vaccinated, or had COVID.”
“If anything, this vaccine is better, safer, and forestalls a worse disease than the influenza vaccine, and yet fewer are mandating it,” Emanuel said. “I think that’s unethical.”
Unvaccinated people could still be accommodated
Much like the DMV does for driver’s licenses, COVID licenses could come with different designations and exemptions.
In fact, digital immunity cards that are similar to what Emanuel imagines already exist in some places.
New York has an “Excelsior Pass” app that operates with a QR code. It shows proof of vaccination or negative test results, which can be scanned like a boarding pass at businesses or venues (it’s already being used at the Barclays Center and Madison Square Garden in New York City.)
The European Union has a “Digital COVID Certificate,” which allows people to travel more freely by showing a QR code proving they’ve either been vaccinated, gotten a negative test result, or recovered from the virus. The new system is up and running in seven EU countries so far.
“You wear an N95 mask, or, we accommodate you in working from home. I mean, look, we have laws that mean you have to make reasonable accommodations for people,” he said. “These aren’t new problems.”
Even if there was a clear, secure system for keeping track of immunity, there’s still one big mystery left to settle. Scientists haven’t yet figured out how, exactly, immunity to the coronavirus works. They don’t know when a COVID-19 license might expire, or how will we know if it has.
“We’re uncertain what the expiration date is, right? All the more reason to have it electronically, where we can change them,” Emanuel said.
Public health experts are recommending that the US resume using Johnson & Johnson’s coronavirus vaccine, after immunizations were halted to investigate reports of rare blood clots.
A Centers for Disease Control and Prevention advisory committee voted 10 to 4, with 1 abstention, on Friday that use of the shot should resume. US health regulators will now craft new language to be included along with the vaccine, warning of the risk of unusual clots in women under 50.
Use of the vaccine had been paused since April 13, amid rare reports that several people who’d gotten the shot had developed a rare type of blood clot, along with a drop in their platelet levels. Platelets are the part of your blood that binds together to form clots.
Officials have identified 15 cases of these clots, called cerebral venous sinus thrombosis (CVST), in women who’d received the shot. Three of the women have died. (A 16th case, in a young man, was observed during J&J’s clinical trials).
The risk is highest for women between the ages of 30 and 39, according to data presented to the committee Friday.
“The last 11 days, to me, have been reassuring because we haven’t identified hundreds of cases across the US,” said Dr. Grace Lee, an associate chief medical officer at Stanford Children’s Hospital , who serves on the committee.
The FDA will change the label on J&J’s shot
J&J’s vaccine was authorized for emergency use by the Food and Drug Administration in February. The FDA will need to update the emergency use authorization for J&J’s vaccine with information warning about the risk of rare blood clots.
Public confidence in the vaccine has dropped significantly in the week and a half since this pause began. Just 19% of Americans would now be willing to get the shot, according to data presented to the advisory group Friday.
J&J representatives said the company’s shot should be reintroduced because it holds up well against virus variants that are spreading in the US. The vaccine is also a single-shot that can be stored in standard refrigerators. That makes it easier to give to people who are homebound, homeless, scared of needles, or incarcerated.
Before the federal pause, 6% of Americans overall said they’d prefer to get a one dose coronavirus vaccine, a statistic that held true regardless of a person’s age, sex, or income.
These unusual cases of CVST clots in patients with low platelets have not been meaningfully connected in any way to the messenger RNA vaccines from Pfizer and Moderna. J&J’s shot is also significantly cheaper than both Pfizer and Moderna’s mRNA vaccines, making it a critical tool in fighting back the virus worldwide.
Without J&J’s vaccine, the CDC’s Dr. Sara Oliver estimated it would take 14 days longer to immunize all adults in the US.
These highly unusual brain clots, though exceedingly rare, have shown up in about one in a million vaccine recipients so far, resulting in one death. More cases may still be unreported (the clots we know about haven’t shown up until 6-13 days after vaccination), making it hard for experts to gauge the true scale of the issue.
Last week, an independent advisory committee that makes vaccine recommendations to the Centers for Disease Control and Prevention made a plea to shot-givers across the US: let’s continue to pause use of this vaccine for now, to gather more data on how many of these dangerous clots are really out there.
But all signs are suggesting that the pause could be coming to an end this weekend.
Insider spoke with five of the 15 CDC vaccine advisory committee members who are meeting on Friday to vote on whether to continue the J&J pause across the US. Barring any more major surprises in the data, they all seemed eager to get the vaccine back into syringes and arms across the nation ASAP.
Millions of Americans got the shot before it was paused
As of last Wednesday, monitoring from the federal government and J&J collectively had flagged a total of seven worrisome clot cases in women under the age of 60, plus one case (during clinical trials) in a young man.
CDC Director Rochelle Walensky hinted at a White House briefing earlier this week that at least another “handful” of cases have been spotted during this week and a half long pause.
Are these one-in-a-million clots caused by the vaccine, or just a fluke?
The clots, cases of cerebral venous sinus thrombosis (CVST) are especially worrisome because they come with low blood platelet levels (thrombocytopenia). That means one of the most common blood clot treatments (heparin) only makes them worse.
Symptoms almost always start with a headache and some chills. Then they progress into severe abdominal pain and loss of consciousness. Eventually they can lead to brain damage and language impairment.
Some on the advisory committee, like Dr. Kevin Ault, an OBGYN at the University of Kansas, still haven’t ruled out the possibility that these cases could just be a fluke, and not related to vaccine administration at all. Others are more convinced this rare but worrisome issue is a highly unusual vaccine reaction.
“I think almost surely this is going to turn out to be related to the vaccine because of the clustering and because of the extraordinary, unusual presentation and findings of the patients who have it,” Dr. Sarah Long, a professor of pediatrics at Drexel University who’s serving on the committee, said.
Without more data, advisors say they are sort of flying blind
Every expert on the committee that Insider spoke to said they want to know if there have been any more cases of the rare blood clots reported in the interim.
That will help them better decide whether to warn certain populations (like young women) about getting this shot.
“We’re a data-driven group. So I want to see data,” Ault said. “We’re glad the system worked, that we were able to find a one in a million potential problem, with this rather unusual diagnosis.”
Advisors may ask for the shot may to come with a warning for women
Long said if cases continue to be clustered in younger women, there could be a warning given out with the shot, “or we could say we recommend it only for men and older women.”
Dr Wilbur Chen, a professor at the University of Maryland School of Medicine on the committee, is hopeful that with more public awareness about the rare condition, it can be recognized early and treated appropriately, avoiding prolonged hospitalizations and more deaths.
“For women 18 to 48 years, or 18 to 50 maybe, we may say ‘you may get vaccinated, but we’d like to just make sure that you are aware of this very rare event,'” he said.
Like putting on a helmet before riding a bike or fastening a seatbelt before driving a car, safety measures can be implemented, he added.
“You can’t completely remove risk with any vaccination, but you can darn well try to make sure that you reduce risk as much as possible,” Chen said. “And that’s what we’re trying to do at this point.”
Ultimately, all of the advisors want us to find a way to reap the benefits of this one-shot vaccine
Experts desperately want to put the J&J shot to use. It is the only one-shot COVID-19 vaccine on the market in the US, making it a critical tool in places like college campuses, homeless shelters, and for homebound adults who may all have logistical challenges to getting a second shot.
“I think it’s extremely unlikely that we’re going to say it’s too risky to use this vaccine,” Dr. Jose Romero, chair of the advisory committee, and director of the Arkansas Department of Public Health, said, suggesting that the issue is likely an “abnormal immune response” that a very small number of patients may have to the shot.
Romero, like others on the committee, is hopeful that the pause will reinforce public confidence in the vaccine safety system. But, with new variants spreading quickly, they all know time is of the essence.
“I’m not willing and eager to continue the pause for much further,” Chen said. “The truth is that the value of the vaccine is proven. 100% efficacy against hospitalization and death is virtually what the data is showing, so that’s terrific. And on the other side for the safety, we think that this [clotting] is super rare.”
‘Are we blowing this up out of proportion?’
Other committee members have warned that the longer this pause goes on, the more hesitant people may be to take the shot once it’s back in action.
“I have mixed feelings,” Lynn Bahta, an infectious disease nurse at the Minnesota Department of Public Health who is also on the panel, said. “Are we blowing this up out of proportion?”
She agreed it’s important that the public knows experts are being cautious and careful, taking vaccine safety seriously, but “to keep delaying is not helpful,” she said.
Some states, like Maine, were planning to rely heavily on J&J to vaccinate homebound residents, and they are now having trouble getting as many people vaccinated as quickly as they had originally intended.
Dr. Walensky has signaled that as soon as the advisory committee makes a final decision on Friday, the CDC and FDA will work together to quickly incorporate their advice into the national vaccination plan.
“I don’t want to get ahead of the advisory committee,” she told NBC’s Today show Thursday, while adding “I’m really hopeful that we’ll be able to use the [J&J] vaccine soon.”