What the COVID-19 vaccine booster data still can't tell us

Asia's Tech News Daily

This past week, a panel of independent FDA advisors has voted to recommend booster shots of both the Moderna and Johnson & Johnson COVID vaccines. 

© Knartz/Deposit Photos An FDA panel paved the way for many vaccinated Americans to receive booster shots.

Although the decisions still need to be confirmed by the FDA itself and the CDC, they pave the way for all at-risk Americans—and everyone who received the J&J vaccine—to receive booster shots. Last month, the FDA approved Pfizer boosters for the same at-risk groups that the FDA panel recommended for Moderna recipients this week, which are people over 65, younger people at high risk for severe COVID, and those who work in high-exposure jobs, like nursing. (The CDC has already approved third doses of Pfizer and Moderna for immunocompromised people, though those aren’t technically boosters.)

In making its decision, the FDA panel relied on data from Israel, and small studies from the companies themselves. But Israel has largely vaccinated its population with Pfizer, not Moderna or J&J. And the panelists repeatedly raised concerns about the depth of drug company data, particularly on side effects.

“I’ve got some real issues with this vote,” said Patrick Moore, a virologist at the University of Pittsburgh School of Medicine, after voting in favor of Moderna’s boosters. “Nonetheless, I want to explain why I voted yes on this. It’s more based on gut-feeling than real serious data.”

As data reporter Betsy Ladyzhets noted in her COVID Data Dispatch Newsletter after the Pfizer booster authorization, there’s a serious lack of home-grown data underlying the entire booster process. Because the CDC doesn’t track all breakthrough infections—just serious ones—federal advisory bodies are relying on data gathered outside the US, and that may not directly pertain to the questions in front of them.

[Related: FDA expert panel recommends all J&J vaccine recipients get a booster]

So how exactly is the FDA making these decisions?

On Thursday morning, two Israeli public health officials presented epidemiological data on the impact of Pfizer booster shots on a surge of COVID cases in August.

Sharon Alroy-Preis, Israel’s director of Public Health Services, said that the country saw a steep dropoff in cases among people over 60 after boosters became available. That data is especially notable because it includes the experiences of millions of people, collected via the country’s national health service. 

“There is no question in my mind that the break of the curve now was due to the booster dose,” she said.

At the FDA presentation, the Israeli officials said that boosters not only reduced the rate of infections, but cut the rate of severe disease by about 70 percent. In people older than 60, they said that boosters reduced deaths by 80 percent.

Most panelists spoke favorably of using the Israeli findings to consider boosters for the Moderna vaccine. “I think we can probably extrapolate from the Pfizer data in Israel,” said Mark Sawyer, a pediatric infectious disease specialist at UC San Diego. “In all other ways, these two vaccines are quite similar.”

But some experts raised questions about whether the two mRNA vaccines are similar enough to draw such firm conclusions. Moore, the Pittsburgh virologist, pointed out that although Pfizer and Moderna’s vaccines rely on the same mRNA technology, Moderna’s vaccine contains several times as much mRNA in each shot.

And one even questioned whether Israel was drawing the right conclusions from its data. “I was not as impressed with the Israeli data as a justification,” said Michael Kurilla, a researcher at the National Institutes for Health. He said that the epidemic curve of Israel’s summer wave—with boosters on hand—looked similar to that of earlier waves, where there weren’t boosters, which led him to wonder if the shots actually made the difference.

It seems clear that mRNA boosters will further protect their recipients against COVID. But when it comes to the larger questions—can we expect full protection against infection? Will boosters hold up against other highly infectious variants, like delta?—the data just isn’t in.

In the case of Johnson & Johnson’s vaccine, the situation is even more complicated. J&J is delivered as a single shot, and the company is asking to add a second dose not because it will head off waning immunity, but because it will bring its efficacy into line with the mRNA vaccines.

That means that Israel’s data, which is focused on waning immunity following mRNA vaccination, is even less applicable.

“The reality is that your vaccine does seem to be holding up quite well in terms of durability,” said Kurilla to J&J officials on Friday, “so the immediate need for a booster is not apparent.”

But J&J’s vaccine has had a lower efficacy against all infections—around 70 percent in the US—even though it’s highly effective against hospitalization and death. “There is room to improve the efficacy,” said Penny Heaton, head of vaccine research for Janssen, J&J’s pharmaceutical division.

Even though the overall efficacy was the central concern of the meeting, J&J is applying for a booster, not a revised primary dose. (Having a one-dose primary regimen means that J&J can still be potentially used to deliver immunity in places where spotty healthcare infrastructure makes it hard to get follow-up doses.) 

Data presented by J&J at Friday’s meeting showed that after two doses, J&J recipients in the United States were 94 percent protected against symptomatic illness. Company presenters also said that the effect was pronounced in the elderly in particular. They argued that the booster was most effective after six months, but that was based on a study that included only 17 people who received a six month booster. In the end, the panel ended up approving the booster after 2 months—essentially a second shot in a two-dose series—over that lack of data.

And J&J’s data was submitted with a caveat: much of it was presented as “unverified by the FDA.” Marks, of the FDA, said that this was because the drug company had delivered data for a trial involving thousands of patients, and FDA reviewers would have needed months to fully verify it.

[Related: The FDA advisory panel recommends Moderna boosters for certain at-risk groups]

The panel also focused on data concerning the safety profiles of booster shots. Because the United States has a unified reporting system for adverse reactions to vaccines, there is a huge amount of national data on the safety of the vaccines as they’re already delivered.

There are two main concerns. The first is blood clotting after the J&J vaccine, which primarily affects women in their 20s to 30s. The recognition of this rare but dangerous side effect led the United States to pause its distribution of the J&J vaccine this spring, breaking the momentum of some outreach campaigns. As of October 5, FDA officials reported 47 cases from J&J. The second is swelling of the heart muscle, known as myocarditis, which has most affected young men, and isn’t as dangerous. There have been 93 cases related to J&J, and 300 following Moderna shots as of June.

Where the panelists expressed concern, however, was the extra dose, particularly in the case of Moderna. Eric Rubin, an infectious disease researcher and the editor-in-chief of the New England Journal of Medicine, said that “the safety data are very thin,” because the Moderna booster dose, which is just half the size of the 100 microgram primary doses, was only tested on 170 people. Instead, many panelists relied on Israeli data, which showed that out of 3.7 million full 100 microgram third doses delivered in Israel, there were only 44 events that required hospitalization or were life threatening.

In the end, many of the panelists said they were comforted by the global data on safety—just not what they’d been presented by drug companies.

Internet Explorer Channel Network
Asia's Tech News Daily
News Related

OTHER NEWS

Microsoft Office has a fresh new look - here's how to update

If you’ve upgraded to Windows 11 and want Microsoft Office to match the look of the company’s latest operating system, then you’re in luck as Microsoft’s visual update for its ... Read more »

DBS CEO says tough for digital banks to gain market share in Singapore

Singapore’s digital banks will find it hard to carve out space in the city-state’s saturated market, said Piyush Gupta, the CEO of DBS Group (DBSM.SI), Southeast Asia’s biggest bank.Online-only banks ... Read more »

The U.S. seized a record $1 billion of bitcoin a year ago. Its value has tripled.

The price of Bitcoin has soared in the year since the U.S. government seized thousands of bitcoins in connection with the illegal Silk Road marketplace. Read more »

The climate crisis could be driving the hybrid salmon population

The climate crisis appears to be increasing the numbers of hybrid salmon in western Canada. The hybrids of Chinook and Coho salmon were discovered in the Cowichan River on Vancouver ... Read more »

New rapid test can measure antibody efficacy against Covid variants, scientists say

Scientists are able to target certain variants for detection, researchers said (Getty Images/iStockphoto) A new rapid test is able to identify how effective a person’s immune system is against Covid ... Read more »

Arthur Labinjo-Hughes: Images show tragic little boy smiling with his mother before she lost joint custody after killing partner

The mother of Arthur Labinjo-Hughes has released photos showing them together and smiling in the years before the six-year-old was killed by his “wicked” stepmother and “pitiless” father. In the ... Read more »

3 reasons why the internet is freaking out about a robot's facial expressions

Another lifelike robot is striking horror into the hearts of humans. Named , the android can convey an impressive range of facial gestures — and people are freaking out. How ... Read more »

Climate Change Is Making Albatross Couples Split Up

Reuters Not all relationships end in “happily ever after,” and birds are no exception. While more than 90 percent of bird species form monogamous couples, many of these will end ... Read more »

The AP Interview: Scientist says omicron was a group find

Read more »

Gran, 75, travels round the whole of England using only her bus pass

Penny Ibbott, 75, raised more than £2000 for her local hospice by bussing around England using her pensioners’ pass (SWNS) A pensioner has travelled 2,200 miles around the edge of ... Read more »

Act now against Omicron to stop new Covid wave, UK ministers warned

Photograph: Neil Hall/EPA UK ministers have been warned they cannot wait for new research on the Omicron variant and must act now to prevent a potentially “very significant wave of ... Read more »

Shielders told to 'use own judgment' at Christmas in 'confusing' No 10 backtrack

The government have told the extremely clinically vulnerable to “use their individual judgement” when it comes to socialising over the Christmas period. (PA Images) The government has issued confusing advice ... Read more »

Piers Morgan blasts Alec Baldwin for 'sickening performance' in first TV interview since 'Rust' set shooting

Watch: Alec Baldwin doesn't feel guilt over fatal Rust shooting Piers Morgan has slammed Alec Baldwin’s interview on the fatal shooting of cinematographer Halyna Hutchins, accusing the actor of “crocodile ... Read more »

Toddler coughs up three-inch leech which had been ‘feeding off them for months'

A three-year-old child had a leech removed from their throat after suffering nose bleeds and coughing for months (Jason Brotherton) A leech who pulled a three-inch leech from the throat ... Read more »

‘Very stringent COVID rules' may be required to contain large Omicron wave, warns Sage

Coronavirus guidance on signs in Nottingham,where one of the first cases of the Omicron variant of COVID-19 was identified last week (Joe Giddens/PA Images via Getty Images) Scientists advising the ... Read more »

Teenager Discovers 3,000-Year-Old Ax from the Bronze Age: 'We Were Just Laughing Our Heads Off'

Teenager Discovers 3,000-Year-Old Ax from the Bronze Age SWNS Milly Hardwick with the ax A day spent metal detecting took an exciting turn for one 13-year-old girl after she discovered ... Read more »

Accountant, 29, raped woman who thought she was having sex with his friend

Ibraheem Egunbambi had been turned down by the woman before he raped her (Reach) An accountant who raped a woman at a party while she thought she was having sex ... Read more »

More than $ 100 million worth of metaverse land was sold in one week

Since Facebook announced its switch to Meta and its future plans to create a metaverse, the existing ones have gained popularity. The biggest racked up $ 100 million selling NFTs ... Read more »

Total solar eclipse: Where to see it live

Tonight from December 3 to 4 there will be a total solar eclipse that will be seen in full from Antarctica where teams of scientists will carry out important studies ... Read more »

Playboy will compete with OnlyFans in the Metaverse and rapper Cardi B will be creative director of the project

Following the death of its legendary founder, Hugh Hefner , in September 2017, the adult entertainment firm Playboy entered a process of restructuring and reinvention. In order to take the ... Read more »

What makes Spotify's Wrapped such a popular end-of-year tradition? FOMO

Obsessed with the Olivia Rodrigo album that came out this year? Did you listen to a podcast for more hours than you realized? Or have you been stuck in the ... Read more »

Get up to $200 in gift cards and free earbuds when you switch to Verizon's Visible wireless service now

— Recommendations are independently chosen by Reviewed’s editors. Purchases you make through our links may earn us a commission. Ready to switch wireless carriers? Visible is giving customers reasons to ... Read more »

Elon Musk replies to a tweet about web 3.0 saying it sounds like "crap"

The term web 3.0 is one that has been getting around a lot lately. It refers to the evolution that many believe the Internet will have, including features such as ... Read more »

Rocket Lab announces the construction of Neutron, a reusable rocket that will become the competition of SpaceX and Blue Origin

The American company founded by Peter Beck spoke about the details of its new rocket, Neutron , in a presentation broadcast live on YouTube. This will aim to put satellites ... Read more »

ISS just had to swerve out of the way of space junk left over from 1994

The International Space Station just had to dodge space junk in orbit, demonstrating the increasing risk to the orbital station and smaller satellites from the proliferation of space trash in ... Read more »

FTC launches lawsuit to block Nvidia's 'anticompetitive' Arm acquisition

The US Federal Trade Commission (FTC) has sued to block Nvidia’s $40bn acquisition of Arm over concerns that the combined firm would stifle competition as well as innovation in the ... Read more »

Workspot DaaS review

Workspot is a SaaS platform and cloud PC service that offers and manages virtual desktops for enterprise organizations. Its key customers have advanced security needs and require high-performing, reliable computing ... Read more »

Pretty much all Wi-Fi routers are vulnerable to attack, study finds

In a shocking revelation, cybersecurity researchers have discovered over 200 bugs in Wi-Fi routers made by nine popular manufacturers, suggesting that millions of the most common devices around the world ... Read more »

Meta head of experimentation says failure is his number one priority

Ime Archibong, Head of New Product Experimentation at Meta (née Facebook), says designing truly innovative products in the tech sector is all about failing, but doing so quickly. Speaking at ... Read more »

How to watch Demon Slayer: Entertainment District Arc online from anywhere

Returning for its second act, Demon Slayer: Kimetsu no Yaiba ‘Entertainment District Arc’ reacquaints Anime fans with Tanjiro Kamoda, a demon slayer apprentice, who finds his path following the slaughter ... Read more »

Forget Spotify Wrapped, groove to the sound of black holes colliding

How do you convey the yawning abyss of infinity that is a black hole to a person who hasn’t immersed themselves in non-Euclidean geometries with infinite dimensions, the ‘math side’ ... Read more »

Why Qualcomm believes its new always-on camera for phones isn't a security risk

One of the biggest new features of the new Snapdragon 8 Gen 1 chipset is an always-on camera. Yes, you read that right. An always-on camera on your phone. It ... Read more »

Where's the snow? Rockies winter starts with a whimper

The Associated PressDrew Darnell rides his skateboard at Cheesman Park Pavilion on Wednesday, Dec. 1, 2021, in Denver. The city is close to breaking a record for its longest streak ... Read more »

Lexus RZ teaser gives us our first glimpse at the firm's first dedicated electric car

Lexus has given us our first look at its next EV. Dubbed the Lexus RZ, a 28 second teaser video (which you can see above) shows the exterior styling from ... Read more »

Ginger writing tool review

It’s been a while since writing assist tools arrived on the market, and they’ve managed to establish a solid reputation among professional writers and even some hobbyist communities. There is ... Read more »

Microsoft Teams update will stop you annoying your colleagues

Microsoft is working on a simple update for Teams that should help address common issues with international collaboration. According to a new entry in the company’s product roadmap, Microsoft Teams ... Read more »

China aiming for DNA storage supremacy as it races towards solid-state device

After Microsoft’s DNA storage announcement and that of the Georgia Tech Research Institute (GTRI), a team from China led by Liu Hong, a professor at Southeast University in the country’s ... Read more »

Microsoft reverses change in Windows 11 that made it hard to switch browsers

Microsoft is reversing a change in the newly released Windows 11 which made it very hard to change your default browser via the system settings. Microsoft released the Windows 11 ... Read more »

US govt phones 'hacked with NSO spyware'

Apple iPhones of at least nine US State Department employees were hacked by an unknown assailant using sophisticated spyware developed by the Israel-based NSO Group, according to four people familiar ... Read more »

Didn't find a Cyber Monday TV deal? These Sony 4K TVs have you covered

Sony makes some top-tier TVs, so it’s well worth paying attention when they’re on sale. And despite Black Friday and Cyber Monday now being over, you can still get some ... Read more »
On free-english-test.com you will find lots of free English exam practice materials to help you improve your English skills: grammar, listening, reading, writing, ielts, toeic