The company’s coming trials will also involve pregnant women and people whose immune systems are compromised.
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Tag Archives: Clinical Trials
Covid Vaccines: Johnson & Johnson’s shot authorized by F.D.A.
The authorization of a third Covid-19 vaccine will bring millions more doses within days. But health officials worry that some people will see the vaccine as the inferior choice.
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Johnson & Johnson’s Vaccine Works Well and May Curb Virus Spread
F.D.A. studies show the shot strongly protects against severe illness and may reduce spread of the virus. But the drugmaker has fallen short of initial production goals.
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Where a Vaccination Campaign Faces Skepticism, War and Corruption
A half-million doses arrived this month in Afghanistan, where many insist the virus isn’t real and vaccines aren’t needed. Those who want the vaccine fear that only the well-connected will receive it.
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Researchers Halt Trials of Promising Sickle Cell Treatment
Two patients in a gene therapy study developed cancer years after treatment. It is not clear whether the therapy was responsible.
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Vaccines Adapted for Variants Will Not Need Lengthy Testing, F.D.A. Says
The agency’s new guidance will speed the development of vaccines that protect against more contagious variants of the coronavirus.
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With Vaccine Delay, Biden Warns of Uncertain End to Pandemic
On a visit to a vaccine manufacturing plant in Michigan, President Biden said the nation could be “approaching normalcy” by the end of the year, but said new virus variants could slow progress.
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Pfizer-BioNTech’s COVID-19 vaccine just got a lot easier to transport and distribute
The COVID-19 vaccine developed by Pfizer and BioNTech now has less stringent and extreme transportation requirements than it debuted with. Originally, the mRNA-based vaccine had to be maintained at ultra-low temperatures throughout the transportation chain in order to remain viable – between -76°F and -112°F. New stability data collected by Pfizer and BioNTech, which has been submitted to the U.S. Food and Drug Administration (FDA) for review, allow it to be stored at temps between 5°F and -13°F – ranges available in standard medical freezers found in most clinics and care facilities.
The vaccine should remain stable for up to two weeks at that temperature, which vastly improves the flexibility of its options for transportation, and last-mile storage in preparation for administration to patients. To date, the vaccine has relied largely on existing “cold-chain” infrastructure to be in place in order for it to be able to reach the areas where it’s being used to inoculate patients. That limitation hasn’t been in place for Moderna’s vaccine, which is stable at even higher, standard refrigerator temperatures for up to a month.
This development is just one example of how work continues on the vaccines that are already being deployed under emergency approvals by health regulators across the U.S. and elsewhere in the world. Pfizer and BioNTech say they’re working on bringing those storage temp requirements down even further, so they could potentially approach the standard set by the Moderna jab.
Taken together with another fresh development, study results from Israeli researchers that found just one shot of the ordinarily two-shot Pfizer-BioNTech vaccine could be as high as 85 percent effective on its own, this is a major development for global inoculation programs. The new requirements open up participation to a whole host of potential new players in supporting delivery and distribution – including ride-hailing and on-demand delivery players with large networks like Amazon, which has offered the President Biden’s administration its support, and Uber, which is already teamed up with Moderna on vaccine education programs.
This also opens the door for participation from a range of startups and smaller companies in both the logistics and the care delivery space that don’t have the scale or the specialized equipment to be able to offer extreme ‘cold-chain’ storage. Technical barriers have been a blocker for some who have been looking for ways to assist, but lacked the necessary hardware and expertise to do so effectively.
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Clinical Trials Are Moving Out of the Lab and Into People’s Homes
After the pandemic forced thousands of trials to shut down, researchers found clever ways to conduct human studies remotely — while reaching more people, quickly and cheaply.
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Covid Vaccines for Kids Are Coming, but Not for Many Months
Pfizer and Moderna are testing their vaccines on children 12 and older and hope to have results by the summer.
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U.K. Approved Study Will Infect Volunteers With Covid
Researchers are hoping to learn things about how the immune system responds to the coronavirus that would be impossible outside a lab.
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U.K. Approves Study That Will Deliberately Infect Volunteers With Coronavirus
Researchers are hoping to learn things about how the immune system responds to the coronavirus that would be impossible outside a lab.
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Coronavirus Vaccine Nears Final Tests in Cuba. Tourists May Be Inoculated.
Amid bread shortages, Cuba gets one step closer to a scientific milestone: the mass production of a coronavirus vaccine invented on the island.
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Some Teens Volunteer for Covid Vaccine Trials to Get Their Lives Back
Immunizing teenagers is a critical part of slowing the pandemic and reaching herd immunity. But enrolling them in clinical trials poses challenges that are very different than wrangling adults.
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My Teens Are Coronavirus Vaccine Guinea Pigs
A health journalist is getting a front-row seat to one of the most-anticipated pediatric trials in history.
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Semaglutide Brings Significant Weight Loss in Obese Patients
In a clinical trial, participants taking semaglutide lost 15 percent of their body weight, on average.
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How Merck’s Vaccine Lost the Covid Race
After ending its own Covid-19 vaccine trials, the company said that it is actively discussing with governments how to help its competitors make their shots.
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Could a Single Vaccine Work Against All Coronaviruses?
Scientists are working on a shot that could protect against Covid-19, its variants, certain seasonal colds — and the next coronavirus pandemic.
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How Scientists Shot Down Cancer’s ‘Death Star’
No drug could touch a quivering protein implicated in a variety of tumors. Then one chemist saw an opening.
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Israel’s Covid Vaccination Results Point a Way Out of Pandemic
Covid cases fell dramatically and quickly among people who were vaccinated, Israeli studies found. It’s the strongest evidence yet that a robust vaccination program can tame the pandemic.
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It’s Time to Trust China’s and Russia’s Vaccines
They, too, work, and they can help fill shortages everywhere.
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After a Rocky Start, Novavax Vaccine Could Be Here by Summer
Even with two other vaccines authorized, Novavax is having no trouble recruiting volunteers for its U.S. trial. If all goes well, the U.S. could see 110 million doses in June.
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Pregnant Women May Receive Covid Vaccines Safely, W.H.O. Says
The change aligns the organization with the guidance from the U.S. Centers for Disease Control and Prevention.
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How the Search for Covid-19 Treatments Faltered While Vaccines Sped Ahead
Vaccine development exceeded everyone’s expectations. But the next few months will still bring many sick people — and doctors have woefully few drugs with which to treat them.
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Vaccine Rollout Gives U.K. a Rare Win in Pandemic
“Vaccination is the one thing we’ve gotten right”: How a country that botched so much of its pandemic response has managed one of the fastest distributions in the world.
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Which Covid Vaccine Should You Get? Experts Weigh the Effect Against Severe Disease
Infectious disease doctors say getting a shot of the J&J vaccine, which has a lower efficacy against the virus than other vaccines, would still be well worthwhile.
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Vaccine Rollout Gives U.K. a Rare Win in Battling Pandemic
“Vaccination is the one thing we’ve gotten right.” How a country that botched so much of its pandemic response has managed one of the fastest rollouts in the world.
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Johnson & Johnson’s COVID-19 vaccine is 85% effective against severe cases, and 66% effective overall per trial data
Another COVID-19 vaccine is almost ready to begin being distributed – a single-shot inoculation made by Johnson & Johnson’s Janssen pharmaceutical subsidiary. The company just released an efficacy report based on data from its Phase 3 trial, which found that the new vaccine is 66% effective overall in preventing moderate to severe incarnations of COVID-19 in those who received the jab, and 85% effective in preventing sever disease.
Those numbers aren’t as impressive as the reported figures for the Moderna and Pfizer/BioNTech vaccines that are already being distributed via emergency FDA approval, both of which reported 90+% efficacy. But Johnson & Johnson’s vaccine is a single shot rather than a two-course treatment, which should make it much easier to distribute much more quickly. The vaccine also showed 100% efficacy in preventing hospitalization or death among participants in the trial, 28 days after vaccination, which is a key measure when considering the broader impact of COVID-19 on healthcare resources, and efficacy varied by region, with the jab proving 72% effective in the U.S. across moderate and severe cases vs. 66% globally.
It’s also important to note that Johnson & Johnson’s Phase 3 trial is happening amid the emergence of new strains of the virus, including much more contagious versions like the UK and South African variants. At the time that both Moderna and BioNTech released their trial data, these variants hadn’t yet emerged or been confirmed by pandemic researchers.
Johnson & Johnson’s vaccine uses a modified version of a common cold virus to deliver DNA that provides a person’s body with instructions on building a replica of the spike protein that SARS-CoV-2 uses to attach to cells. The modified adenovirus can’t replicate in human cells, however, meaning it won’t lead to illness – only an immune response that can later be employed to combat contracting the virus that leads to COVID-19. This adenovirus method is much more proven in terms of use in human patients vs. the mRNA method that the other vaccines currently in use employ.
All of which is to say, despite headline numbers that appear to fall short relative to the data we’ve seen from Moderna and Pfizer, this Johnson & Johnson report is actually very encouraging. The company says it expects to file a request for an Emergency Use Approval (EUA) from the FDA in February, which could see it begin to be distributed next month, adding yet another weapon in the arsenal to combat the global pandemic.
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Johnson & Johnson’s Vaccine Offers Strong Protection but Fuels Concern About Variants
The vaccine’s efficacy rate dropped from 72 percent in the United States to just 57 percent in South Africa, where a highly contagious variant is driving most cases.
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One Dose Now for Everyone Most Likely to Die
Forget boosters and more trials. America’s overly prudent vaccination strategy is killing people.
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Pregnant Women Get Conflicting Advice on Covid-19 Vaccines
The W.H.O. and the C.D.C. provide differing views, and experts partly blame a lack of data because expectant mothers have been excluded from clinical trials.
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Novavax’s Vaccine Works Well — Except on Variant First Found in South Africa
An early analysis in Britain found that the vaccine had an efficacy rate of nearly 90 percent. But in a small South Africa trial, the efficacy rate dropped to just under 50 percent.
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Is It OK to Enroll in a Covid-19 Vaccine Trial If I Might Drop Out?
The magazine’s Ethicist columnist on the importance of control groups and elderly parents’ risky behavior.
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Moderna says it’s making variant-specific COVID-19 vaccines, but its existing vaccine should still work
Moderna has detailed some of the steps it’s taking to ensure that its vaccine remains effective in the face of emerging strains of the SARS-CoV-2 virus that leads to COVID-19. These include testing how adding a second booster, for a total of three shots, works with its existing COVID-19 vaccine, and also developing a strain-specific variant designed to target spike proteins on the new variants of the virus that were first identified in the UK and in South Africa.
The company is pursuing these measures “out of an abundance of caution,” the biotech firm said in a press release, since early studies show that the existing vaccine continues to prove effective against these new strains, albeit with some loss of efficacy specifically with the B.1.351 variant which was first identified in patients in South Africa. Even so, it’s heartening to see the company moving quickly to address the virus’ mutation, since it’s likely that similar adaptations will be required longer term to keep COVID-19 in control even once the current pandemic is ended.
Further, Moderna says that in fact, it expects both its forthcoming candidate and its existing booster vaccine should be able to provide additional immunity posting capabilities when used in combination with “all of the leading vaccine candidates” on the market. That means the company believes it could be used in combination with the Oxford or Pfizer/BioNTech vaccines to boost immunity, which could be helpful in cases where supplies of one or the other are low and there’s an urgent need to provide a booster in a timely manner.
The best news of all of this is, of course, that Moderna now has evidence that suggests the mRNA-based vaccine it’s already providing to people globally will still provide protection against SARS-CoV-2, and by extension, COVID-19. Specifically for the UK variant in particular, the study data shows no reduction in immune performance in patients who received the vaccine. As for the South African variant, that reduction in efficacy mostly translates to a potential of quicker waning of immunity provided by the jab – which hopefully just means people will need another jab sooner than expected, but shouldn’t lead to any dramatic changes in our combined global approach to providing inoculations, especially initially.
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A Mix of Pride and Doubts as Modi Launches India’s Covid-19 Vaccine Drive
One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.
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Johnson & Johnson Expects Vaccine Results Soon but Lags in Production
The U.S. needs J.&J.’s one-shot vaccine more than ever. But the company is behind on manufacturing promises made in its Operation Warp Speed contract.
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Eli Lilly’s Alzheimer’s Drug Shows Promise in Small Trial
Participants with the disease still declined, but much more slowly than those receiving a placebo, investigators say.
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Covid Deaths Lowered in Trial of Tocilizumab and Sarilumab
The big dip in mortality shown in the trial of about 800 patients has caught some experts by surprise because previous studies of the drugs showed little benefit.
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Study Says Blood Plasma Reduces Risk of Severe Covid-19 if Given Early
Thousands of people received convalescent plasma as an experimental treatment for Covid. A new study shows that it works — but only when given within a few days of the onset of illness.
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Warning of Shortages, Researchers Look to Stretch Vaccine Supply
The N.I.H. and Moderna are examining whether doses of Moderna’s coronavirus vaccine can be halved to double the supply, while scientists look for other ways to extend availability.
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As Rollout Falters, Scientists Debate New Vaccination Tactics
Should second doses be delayed? Should most adults receive half-doses? Scientists are pondering ways to get more shots into more arms.
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India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other
The approvals, which include a shot developed by Bharat Biotech, an Indian pharmaceutical company, begin a vast campaign to inoculate the hard-hit nation’s 1.3 billion people.
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Britain Opts for Mix-and-Match Vaccinations, Confounding Experts
If a second dose of one vaccine isn’t available, another may be substituted, according to new U.K. guidelines.
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Why Covid-19 Vaccines Take a While to Kick In
Reports of Covid-19 cases that appeared shortly after a single shot of a two-dose vaccine shouldn’t cause concern.
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U.K. Authorizes Covid-19 Vaccine From Oxford and AstraZeneca
Health officials hope to soon vaccinate a million people per week as the country’s hospitals are overwhelmed by cases of a new, more contagious coronavirus variant.
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Britain Authorizes Covid-19 Vaccine From Oxford and AstraZeneca
Health officials are hoping to soon vaccinate a million people per week as the country’s hospitals are overwhelmed by cases of a new, more contagious variant of the virus.
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Britain Authorizes Covid Vaccine From Oxford and AstraZeneca
Health authorities are hoping to soon vaccinate a million people per week as the country’s hospitals are overwhelmed by cases of a new, more contagious variant of the virus.
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A Chinese Covid-19 Vaccine Has Proved Effective, Its Maker Says
Sinopharm, a state-controlled company, said its candidate was shown to be 79 percent effective in interim late-stage trials, bringing a China-made vaccine a step closer to approval for mass use.
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China Has All It Needs to Vaccinate Millions, Except Proof Its Vaccines Work
Across the country, local governments plan to inoculate 50 million people by early next year. But the vaccines have not officially been approved.
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For Covid-19 Vaccines, Some Are Too Rich — and Too Poor
Global inequality is shaping which countries get vaccines first. In South Africa, people’s best chance for vaccines anytime soon is to join an experimental trial.
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