COVID-19 vaccine trial Archives - Page 4 of 13

Pfizer seeks FDA blessing for COVID-19 vaccine booster

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older.

The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55.

The latest data indicate that a third dose of the Comirnaty vaccine boosts antibody titers and continues to be well tolerated.

Get the full story from our sister site, Drug Discovery & Development.

Pfizer seeks FDA blessing for COVID-19 vaccine booster

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older.

The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55.

The latest data indicate that a third dose of the Comirnaty vaccine boosts antibody titers and continues to be well tolerated.

Trial investigators administered the booster between 4.8 and 8 months after giving the second dose of the COVID-19 vaccine.

The booster resulted in strong protection against the original or wild-type strain of SARS-CoV-2. Specifically, 99.5% of participants had a four-fold increase in neutralizing antibody levels after the third dose.

The most common side effects were similar to those from earlier doses, including injection-site soreness, fatigue, headache, muscle aches and chills.

The comp…

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.

Get the full story from our sister site, Drug Discovery & Development.

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…

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…

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…

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 …

U.S. government withholds funding from Novavax

Although Novavax (NSDQ:NVAX) disclosed the news in a July 31 SEC filing, investors apparently didn’t react to the development until today. In mid-day trading, the stock dipped 20% to $188.18. The company’s stock had surged earlier in the week.

In the SEC filing, Novavax said the U.S. government told the company to align its analytic methods with the FDA before planning additional domestic manufacturing. Furthermore, the government told Novavax that it would withhold funding for additional manufacturing until the company had done so.

The company had landed a $1.75 billion contract as part of the U.S. government’s Operation Warp Speed program to produce a COVID-19 vaccine. The U.S. agreed to purchase 110 million doses of the vaccine after it receives emergency use authorization.

Similar to Moderna, the COVID-19 vaccine will be Novax’s first commercial product.

The New York Times report suggests that Novavax has struggled to convince the FDA th…

Novavax stock surges after striking EU COVID-19 vaccine deal

Novavax (NSDQ:NVAX) saw its stock jump more than 20% in afternoon trading after the European Commission agreed to purchase up to 200 million doses of its vaccine.

The Gaithersburg, Md.–based vaccine maker announced in March that its NVX-CoV2373 vaccine was 96.4% effective against the original SARS-CoV-2 strain in a U.K. trial. The efficacy in a later trial conducted in the U.S. and Mexico was 90.4%, according to a June NIH press release.

But the company had been slow to get its vaccine onto the market. In the U.S., the company plans on filing for emergency use authorization in late September.

Get the full story from our sister site, Drug Discovery & Development.