COVID-19 vaccines Archives - Page 10 of 24

Janssen COVID-19 booster leads to nine-fold increase in neutralizing antibodies

Johnson & Johnson (NYSE:JNJ) has announced that a booster of its viral-vector COVID-19 vaccine led to considerable increases in coronavirus spike-binding antibodies, according to interim data from two Phase 1/2 trials known as VAC31518COV1001 and VAC31518COV2001.

In particular, the boosters led to a nine-fold increase in antibodies relative to levels 28 days after administering the prime dose.

Janssen noted robust increases in participants aged 18 to 55 and those 65 and older who received a reduced booster dose.

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Janssen COVID-19 booster leads to nine-fold increase in neutralizing antibodies

Johnson & Johnson (NYSE:JNJ) has announced that a booster of its viral-vector COVID-19 vaccine led to considerable increases in coronavirus spike-binding antibodies, according to interim data from two Phase 1/2 trials known as VAC31518COV1001 and VAC31518COV2001.

In particular, the boosters led to a nine-fold increase in antibodies relative to levels 28 days after administering the prime dose.

Janssen noted robust increases in participants aged 18 to 55 and those 65 and older who received a reduced booster dose.

The company has submitted the data to the pre-print publisher medRxiv.

Johnson & Johnson had found earlier that the Ad26.COV2.S vaccine elicited significant protection against COVID-19 eight months after the initial vaccination. Those data were published in NEJM.

CDC said on August 18 that recipients of the Johnson & Johnson vaccine will likely benefit from a booster, but that more data are required.

The company i…

COVID-19 vaccine mandates likely to accelerate

Pfizer-BioNTech COVID-19 vaccine. [Image courtesy of Wikimedia Commons]

Now that the FDA has approved the BioNTech-Pfizer vaccine for those 16 and older, it is likely that vaccine mandates will become more common.

Following the approval of the vaccine, the Pentagon, CVS, Chevron, Disney World, New York and New Jersey schools, and other organizations have signaled their intent to enforce vaccine mandates.

Yesterday, President Joe Biden called on a variety of organizations to pursue vaccine mandates. “If you’re a business leader, a non-profit leader, a state or local leader, who has been waiting for full FDA approval to require vaccinations, I call on you now to do that,” he said.

“The pandemic of the unvaccinated is a tragedy that is preventable,” Biden said. “People are dying and will die who don’t have to.” People who haven’t been vaccinated should “do it now,” he urged.

The FDA approval…

Zydus plasmid DNA vaccine wins EUA in India

For all of the varied work on COVID-19 vaccine candidates, the majority of vaccines to win emergency use authorization have fallen into a handful of categories, including mRNA, viral vector and inactivated vaccines.

Zydus Cadila (NSE: CADILAHC) is adding more diversity to the pool with its ZyCoV-D vaccine, which recently received emergency use authorization (EUA) in India. The vaccine will be available for people 12 and older.

Healthcare workers can administer the plasmid DNA vaccine with a needle-free applicator. Zydus is using the PharmaJet (Golden, Colo.) Tropis needle-free injection system for this purpose. Zydus claims that the needle-free system can reduce side effects.

The PharmaJet Tropus needle-free delivery system.

The vaccine is also unique in that it requires three doses rather than one or two. The last two doses are administered 28 and 56 days after the first.

The need for t…

Canada to donate 10 million J&J vaccine doses to developing countries

Initially facing a shortage of COVID-19 vaccines, Canada has now vaccinated a greater share of its population than the U.S.

Now, the country is planning on donating 10 million doses to low- and middle-income countries via the COVAX initiative, a global program that aims to distribute vaccines in developing nations.

The country had faced controversy earlier this year for tapping into a supply of vaccines initially set aside for COVAX.

The Africa Center for Disease Control (AfricaCDC) recently announced that it had chosen the Johnson & Johnson COVID-19 vaccine. The vaccine has the advantage of having straightforward storage requirements and is available as a single dose.

To date, Canada has committed 40 million doses to the COVAX program and additional financial support for the initiative.

In June, Canada rejected some 300,000 doses of U.S.-made Janssen vaccine over potential contamination problems.

FDA allows Pfizer-BioNTech and Moderna boosters in the immunocompromised

The FDA has authorized boosters for certain vaccinated individuals, but the agency believes there is insufficient evidence to recommend boosters to the broader population. The amended EUA applies to the Pfizer-BioNTech or Moderna vaccines.

The individuals covered in the EUA include solid organ transplant recipients and people with other medical conditions leading to a moderate to severe state of immunocompromise.

Recipients of the Janssen vaccine are not currently eligible for a booster.

The amended EUA recommends that health officials administer the third dose at least 28 days after the second dose of the same vaccine. The EUA allows the use of the Moderna booster for patients who are 18 years old or older. It permits the administration of the third dose of Pfizer-BioNTech vaccine in individuals 12 or older.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are pa…

WHO to test three anti-inflammatory therapies in COVID-19 patients

The World Health Organization (WHO) is adding three anti-inflammatory therapies to its global Solidarity COVID-19 trial. WHO is referring to the expanded trial as “Solidarity PLUS.”

WHO will investigate the following drugs as potential treatments for hospitalized COVID-19 patients:

Ipca Laboratories’ artesunate is an FDA-indicated treatment for severe malaria in adult and pediatric patients. Last year, the drug became the only drug with that indication. In vivo and in vitro SARS-CoV-2 studies involving artesunate have been promising. A study published in ACS Chemical Neuroscience concluded that the drug could potentially treat neurological symptoms related to COVID-19. Novartis’s Gleevec (imatinib mesylate) is a kinase inhibitor. FDA indications for the drug include a range of cancers, including leukemia and gastrointestinal stromal tumors. A separate group of researchers is also evaluating the safety and efficacy of the drug in hospitalized adults with COVID-19.…

Prominent COVID-19 vaccine makers continue to make case for boosters

Image from Sam Moqadam on Unsplash

The case for boosters has gained ground amidst the surge in COVID-19 infections over the past month.

BioNTech CEO Özlem Türeci recently recommended that health officials administer a third dose six to 12 months after the second dose to “maintain the highest level of protection.”

Pfizer CEO Dr. Albert Bourla has made similar recommendations.

Pfizer and BioNTech are working together on developing variant-specific vaccines, including one for Delta, but Türeci recently said that their current vaccine would be an effective booster.

In its most recent earnings presentation, Pfizer released early data concluding that a third dose of its COVID-19 vaccine led to a substantial increase in SARS-CoV-2 neutralization titers. For the wild-type virus, titers increased more than five to eightfold. For the Delta variant, neutralization titers increased more than fivef…

Aldevron and Ginkgo Bioworks announce mRNA manufacturing ‘breakthrough’

The partnership between Aldevron (Fargo, N.D.) and Ginkgo Bioworks (Boston) has resulted in an improvement in the manufacturing yield of the vaccinia capping enzyme (VCE).

VCEs are often used in the production of mRNA vaccines and therapeutics.

The new production protocol is more than 10 times more efficient than the prior process, according to a statement from both firms. The gene therapy company Aldevron will have exclusive rights to the protocol conditions of the manufacturing process. Ginkgo Bioworks specializes in synthetic biology.

“Aldevron’s industry-leading products and services are the foundation for some of the most exciting advances in biological science today,” said Jason Kelly, CEO of Ginkgo Bioworks, in a statement.

Tom Foti, president of Aldevron’s protein business unit, predicted the new production method would “accelerate mRNA therapeutic and vaccine development for manufacturing teams around the world.”

Ginkgo Bioworks is…

COVID-19 vaccines driving a decoupling between infections and deaths

[Image courtesy of CDC]

In the U.S., areas with low vaccination rates have seen an uptick in vaccinations, while authorities in many highly-vaccinated areas have recommended mask-wearing and similar COVID-19 policies.

While Delta has blunted COVID-19 vaccines’ ability to reduce transmission, vaccines remain effective at saving lives. During the peak of the prior wave, thousands of people died daily from the novel coronavirus. But now, with new cases surpassing 200,000 each day, death rates have only ticked up gradually in the U.S. as a whole. Deaths, however, have marched up considerably in states with low vaccination rates, such as Louisiana, Arkansas and Florida. In such areas, COVID-19 hospitalizations are roughly in line with summer 2020 levels.

“There’s more of a decoupling” between the vaccinated and unvaccinated, said Dr. Monica Gandhi, a professor of medicine at the University of California, Sa…

Study finds mild short-term impact from myocarditis after COVID-19 vaccination

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

Despite the rare risk of myocarditis in children, the benefits of the Pfizer-BioNTech BNT162b2 vaccine likely outweigh the risks, according to a recent JAMA Cardiology report.

A separate pre-print study found that adolescents’ risk of contracting myocarditis is substantially higher after contracting COVID-19 than from receiving mRNA vaccines targeting the novel coronavirus. An earlier JAMA Cardiology article reached similar conclusions, reporting that “as many 1% of highly fit athletes with mild COVID-19 infection have evidence of myocarditis on [cardiac] MRI.”

A separate study in Circulation estimated that between 12–20% of hospitalized COVID-19 patients develop myocarditis.

The recent JAMA report did, however, suggest that the second dose of the BNT162b2 vac…

COVID-19 vaccination halves reinfection risk according to CDC study

[Image courtesy of Wikipedia]

Among those with previous COVID-19 infections, those who were unvaccinated were 2.34 times more likely to get infected again than vaccinated individuals, according to a CDC report.

“Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country,” said CDC director Dr. Rochelle Walensky in a statement.

The study drew from COVID-19 cases in Kentucky from May to June 2021, before the Delta variant became widespread.

The study had 246 cases of COVID-19 and 492 controls. In the total population, 83% had prior COVID-19 infections between October and December 2020.

The study authors noted that the continued emergence of new variants could influence infection-acquired immunity. Prior studies have shown that natural infection leads to a weak or inconsistent response …