There is a new vaccine against Covid 19 that is very effective against the virus. On face value it may not seem as effective as the other two vaccines, but that’s not the whole story. Remember, in a good year, the flu vaccine is 60% effective. These vaccines have exceeded expectations. Here is a very good Q+A on the vaccine from the Wall Street Journal. Following that is Dr. Paul Sax’s blogpost from today with his feelings on this new development.
J&J’s Covid-19 Vaccine: How Effective Is It and When Will It Be Available?
The single-dose vaccine was 66% effective in a late-stage study and the company expects to seek authorization in early February
Jan. 29, 2021 12:13 pm ET
Johnson & Johnson reported that its single-dose Covid-19 vaccine protected against Covid-19 in a late-stage trial, while being generally safe and well tolerated. Here’s what we know and don’t know:
How effective is J&J’s vaccine?
It appears to work well. The vaccine was 66% effective in a late-stage study with about 44,000 volunteers ages 18 years and older, according to the company. That indicates the shot protects adults from moderate to severe Covid-19, the disease caused by the coronavirus. When focusing on preventing severe disease specifically, the vaccine was even more effective, posting an 85% rate. By comparison, an annual flu shot is considered to work well if it is 60% effective.
How does it compare to the effectiveness of Pfizer and Moderna shots?
The vaccine from Pfizer Inc. and partner BioNTech SE was 95% effective at preventing people from getting sick with Covid-19 in its late-stage study, while the Moderna vaccine was 94.1% effective. J&J’s shot didn’t work as well in its trial. It can be tricky to compare across trials, however. And the timing of the testing might have played a role, as J&J’s took place while new coronavirus variants emerged. Vaccines don’t appear to work as well against the variant first identified in South Africa, in particular. J&J’s vaccine was 57% effective in South Africa compared with 72% in the U.S. during the late-stage trial. Several vaccines have performed above what health experts say is needed to protect many people and provide the community immunity needed to move to a post-pandemic life.
When might the vaccine become available?
J&J says it expects in early February to ask the U.S. Food and Drug Administration to authorize the use of its vaccine. If the FDA takes the same amount of time as it did to review and authorize the first two Covid-19 vaccines—about three weeks—it could make a decision later in February or by early March. J&J has been making doses while testing its shot, so it could be ready to ship supplies quickly after getting a go-ahead from regulators.
What are the side effects of J&J’s vaccine?
The most common symptoms after vaccination were fatigue, headache, muscle ache and injection-site pain in an early-stage study. In the late-stage study, J&J said a small percentage of subjects had fever, and there were no severe allergic reactions.
Which vaccine should I get?
The first one you can, health authorities say. It is possible that individuals won’t have much of a choice because of limited supplies and the vaccination site might only offer one of the shots. If you do have a choice, there are some key differences that could guide your decision. J&J’s vaccine, while appearing less effective in studies, is given as a single dose, which may be a more convenient option than the two doses required for both of the Pfizer and Moderna vaccines, given three or four weeks apart. Only the Pfizer vaccine is authorized for adolescents 16 and 17 years old, while Moderna’s is cleared for those 18 and older. J&J’s also is likely to be cleared for adults because only people 18 years and older were in the company’s large clinical trial.
How was J&J’s vaccine tested?
Starting in September, J&J enrolled more than 44,000 adults in the U.S. and several other countries including Brazil and South Africa in a clinical trial. Subjects received a single dose of either the vaccine or a placebo. Researchers counted how many people subsequently contracted moderate to severe Covid-19 starting 14 days after vaccination, until a certain number of people fell ill. Researchers then examined whether there were fewer vaccinated people than unvaccinated people among the Covid-19 cases.
How does J&J’s vaccine work?
The vaccine uses a harmless type of virus, called an adenovirus, which can cause cold symptoms. It is modified to contain the DNA of the so-called spike protein found on the surface of the new coronavirus. Once injected, the adenovirus carries the DNA payload into human cells. Once inside the cells, the DNA payload causes the production of the spike protein. This, in turn, triggers an immune response that can later defend against the real coronavirus if a vaccinated person is exposed to it.
What don’t we know about J&J’s vaccine?
We don’t know its safety and effectiveness in children, or among pregnant women, their fetuses or nursing babies. We also don’t know how long protection from the vaccine will last. The company is conducting a separate study testing whether adding a second dose improves its performance.
Does J&J’s vaccine protect against new coronavirus strains?
The vaccine was less effective in South Africa and Latin America than in the U.S. That could be a sign the vaccine is less protective against strains circulating in those regions, though J&J is still conducting that analysis. Even at the lower level of effectiveness in South Africa and Latin America, health experts say, J&J’s vaccine works well. The company said it is working on a version of the vaccine targeting the South Africa variant.
January 31st, 2021
Are We Expecting Too Much from Our COVID-19 Vaccines?
Photo by Wolfgang Hasselmann on Unsplash.
There are no absolutes in life. And nothing is perfect.
Tom Brady isn’t always in the Super Bowl (hard to believe). Serena Williams occasionally exits tennis tournaments in the early rounds. Tom Hanks and Meryl Streep sometimes appear in movies that are stinkers.
I’ve always thought that Frank Lloyd Wright’s Guggenheim Museum in New York fits horribly on Fifth Avenue, and looks like a toilet (not an original thought). Even the Beatles unfortunately released Revolution 9, an interminable abstract sound collage of musical “art” — my vote for their very worst “song”.
So why, then, are we expecting perfection from our COVID-19 vaccines? The vaccines developed in record time and our best chance at controlling the pandemic?
That’s what struck me late last week when we heard the results of two important COVID-19 vaccine studies, one from Novavax, the other from Johnson & Johnson.
Both vaccines worked, but there’s a distinct tone of disappointment in some of the news coverage.
In the Novavax trial, which used a two-shot protein-adjuvant strategy, the vaccine was 90% effective in the United Kingdom, but only 49% effective in South Africa, with most of the vaccine failures in South Africa the result of the B.1.351 variant.
Johnson & Johnson used an adenovirus 26 (Ad26) vector vaccine and one shot. It was only 72 percent effective in preventing COVID-19 in the United States and just 57 percent in South Africa.
(Italics mine, to make a point.)
With the 95% protection in the Pfizer and Moderna studies of mRNA vaccines, the headlines making unfavorable comparisons are understandable.
But there’s a lot to like about these results, even based on the limited information available in the press releases.
Both studies faced a more challenging COVID-19 transmission dynamic than Pfizer and Moderna — with a global surge in cases and emerging variants that are more contagious, potentially of greater disease-causing virulence, and harboring antigenic properties making them more evasive of vaccine protection. We simply don’t know how the Pfizer and Moderna vaccines would perform under similar pressures.
And both vaccines appear to prevent severe disease, a critically important endpoint. (Numbers are small in the Novavax press release, but still in the right direction.) Since it’s highly unlikely we’ll ever be able to eliminate SARS-CoV-2 from the planet, converting it from something that fills our hospitals into a nuisance respiratory virus — causing a mild cold or sore throat — is a welcome trade-off.
Prevention of severe disease is something all of these vaccines appear good at, according to a summary by my Boston ID colleague Dr. Roby Bhattacharyya.
Or, as put quite succinctly by longtime vaccine expert Dr. Paul Offit:
You want to stay out of the hospital, and stay out of the morgue.
More good news — neither vaccine requires the kind of ultra-cold storage of the mRNA vaccines, a huge plus for distribution. And a one-dose strategy could greatly speed getting a larger number of people with at least some protection.
Meanwhile, in related news, reports of COVID-19 vaccine “failures” continue to make headlines, again making me wonder — why are our expectations so high? Did we really expect these vaccines to be perfect? We’re still in the middle of a pandemic, with only a small fraction of the population vaccinated.
Of course, cases of COVID-19 will continue to occur, even after vaccination. They are not 100% effective, even under the best-case scenario of a clinical trial. What we’re hoping for with vaccination is that there will be fewer cases, that they will be less severe, and hopefully less contagious.
I’m highlighting the distinction between “fewer/less” versus “zero” because there’s reason to expect that real-world effectiveness will not match clinical trial efficacy. We must guard against reports of vaccinated individuals who get COVID-19 as evidence that they don’t work at all.
We don’t know, for example, how they will perform in the frail elderly or the severely immunocompromised — people too infirm to participate in the clinical trials, yet appropriate targets for early immunization. Plus, the variants may make their effectiveness lower than in clinical trials, which is why sequencing of cases that occur after vaccination will be critical.
The true effect on disease incidence must await large, population-based studies — studies we’re likely to see relatively soon, such as these encouraging preliminary data from Israel, which so far has vaccinated a higher proportion of its population than any other country.
Meanwhile, let’s stop expecting perfection, carefully review the emerging research, and focus on getting as many people vaccinated as fast as possible.
And enjoy this amazing medley as a Revolution 9 palate cleanser.
