COVID-19 vaccine trial Archives - Page 10 of 13

Novax could have one of the most-effective COVID-19 vaccines

Novavax may not be the best-known vaccine developer, but its COVID-19 vaccine offers performance in line with those from Moderna and Pfizer. Its vaccine was 96.4% effective at preventing COVID-19 caused by the original strain of the virus in a Phase 3 study. The Moderna and Pfizer vaccines offered efficacy in the mid-90% range in similar studies.

But in the efficacy of the Novavax NVX–CoV23 vaccine dipped to 86.3% when it came to protecting against the U.K. variant (B.1.1.7).

Because of subtle differences in trial designs and timing, it is difficult to do head-to-head comparisons of clinical trials. The Phase 3 clinical trial results for the Moderna and Pfizer-BioNTech vaccines did not include data on SARS-CoV-2 variants.

In a separate Phase 2b trial in South Africa, the Novaax vaccine has an efficacy of 55.4% in HIV- negative trial volunteers. The majority of COVID-19 cases in the country are the result of the B1.351 variant. The South Africa and Brazil…

Tinnitus reports grow amid COVID-19 vaccinations

Photo by Kimia Zarifi on Unsplash

A handful of patients in Johnson & Johnson’s Phase 3 COVID-19 clinical trial complained of tinnitus, or ringing in the ears.

After reporting on the subject, we’ve received a steady stream of reports from Moderna and Pfizer-BioNTech vaccine recipients who experienced tinnitus.

The U.S. Vaccine Adverse Event Reporting System database cites 152 reports of tinnitus among 25,072 COVID-19 recipients of vaccines from Pfizer-BioNtech and Moderna. The database also has 11 reports of sudden hearing loss and 39 reports of hypoacusis (loss of hearing acuity).

A U.K. database cataloging adverse events related to AstraZeneca and Pfizer-BioNtech vaccines also lists a number of cases of tinnitus. In a summary of adverse reaction reports for the 54,180 recipients of the AstraZeneca vaccine from Jan. 1 to Feb. 28, there were 320 tinnitus reports. For the Pfizer-BioNTech vacc…

39-year old Utah woman dies after getting second dose of COVID-19 vaccine

Image from Nataliya Vaitkevich via Pexels

Researchers have not found causal links between COVID-19 vaccination and deaths, but a handful of post-vaccine deaths are making headlines.

One such case is the death of Kassidi Kurrill, a 39-year-old resident of Ogden, Utah, who recently passed away four days after receiving the second dose of Moderna COVID-19 vaccine.

Before her death, Kurrill complained that her heart was racing and was later rushed to the emergency room. Doctors reported that “her liver was not functioning,” according to her father, Alfred Hawley, in an interview with Salt Lake City–based KUTV.

Kurrill died some 30 hours later.

She reported having no significant side effects from the first vaccine dose.

Her family is awaiting autopsy results.

A Miami physician died from immune thrombocytopenia in January after receiving a COVID-19 vaccine, but researchers have n…

Why emergency authorization of COVID-19 therapies could pose thorny regulatory questions

Image by Arek Socha from Pixabay

Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications.

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard,” said Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland.

The FDA’s decision to grant emergency use authorization to investigational vaccines could lead to the development of a “marketplace” where vaccines are deemed “good enough to be authorized, but never approved,” Doshi opined in the public comment period of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Johnson & Johnson’s vaccine.

Further compl…

Intranasal COVID-19 vaccines could be on the horizon

Image courtesy of AltImmune

All of the COVID-19 vaccines authorized to date are delivered via intramuscular injection. But the intranasal vaccines that are now in development could lead to a more diverse vaccine landscape.

The company Altimmune (Gaithersburg, Md.) recently launched a Phase 1 clinical trial to test its single-dose adCOVID intranasal vaccine in 180 adult volunteers. Bharat Biotech (Hyderabad, India) is launching its own tests. In Europe, a newly-founded company known as Rokote Laboratories (Joensuu, Finland) is doing the same.

Intranasal vaccines could offer key advantages over intramuscular vaccines, said Dr. C. Buddy Creech, a professor within the Division of Pediatric Infectious Diseases at the Vanderbilt University School of Medicine.

First, an intranasal vaccine could trigger a broad immune response that includes both systemic immunity and local immunity in the respirator…

Is there a link between Bell’s palsy and COVID-19 vaccines?

Image from Nataliya Vaitkevich via Pexels

One adverse event common to clinical trials for currently authorized COVID-19 vaccines is Bell’s palsy, an asymmetrical weakness or paralysis of the face that is often temporary.

Two vaccine recipients in the Johnson & Johnson Phase 3 clinical trial developed Bell’s palsy, as did two people in the placebo group. Another patient developed facial swelling and “droopiness” without facial asymmetry. A clinical trial investigator concluded that this event was unrelated to the vaccine.

Three vaccine recipients in the Moderna Phase 3 clinical trial developed Bell’s palsy, as did one in the placebo group. In the corresponding Pfizer-BioNTech study, four vaccine recipients developed Bell’s palsy, but no participants in the placebo group did.

The three Phase clinical trials involved some 30,000 to 40,000 volunteers.

The numerical imbalance between the …

FDA advisory panel endorses J&J’s single-dose COVID-19 vaccine

The U.S. is poised to have three vaccines available after an FDA advisory panel unanimously recommended that the agency authorize the Ad26.COV2-S vaccine from Johnson & Johnson.

Although the recommendations of the independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) are nonbinding, the agency almost always heeds them. There are 22 members in the panel.

The agency will likely authorize the vaccine quickly.

J&J’s vaccine differs from the mRNA vaccines currently available in that it uses an adenovirus vector, will be available as a single dose and can be stored at typical refrigeration temperatures.

While the vaccine’s overall efficacy of 66% trails that of vaccines from Pfizer and Moderna by nearly 30 percentage points, the vaccine offers strong protection against severe COVID-19 disease.

VRBPAC member Dr. Archana Chatterjee shed light on the panel’s unanimous support of the vaccine, even though some member…

4 things to keep in mind ahead of the FDA meeting on J&J vaccine

Tomorrow, an FDA advisory panel will convene to evaluate the Ad26.COV2.S COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ).

The vaccine has a favorable safety profile and significant efficacy after a single dose.

Here are several themes that are likely to be among the topics discussed in the Vaccines and Related Biological Products Advisory Committee meeting.

1. The J&J vaccine uses an adenovirus vector as opposed to mRNA

In contrast to Moderna and Pfizer’s mRNA vaccines, J&J’s vaccine uses a replication-incompetent recombinant adenovirus type 26 as a vector to express the SARS-CoV-2 spike protein.

The Ad26 platform is not new, having been administered to nearly 200,000 people in other vaccine candidates.

AstraZeneca’s COVID-19 vaccine also uses an adenovirus vector, as does the Rusian vaccine Sputnik V.

2. Efficacy is in the ballpark of 67%

The Moderna and Pfizer two-dose vaccines had efficacy rates in the range o…

Is COVID-19 herd immunity elusive or within reach?

This transmission electron microscope image shows SARS-CoV-2 – the virus that causes COVID-19 – isolated from a patient in the U.S. Image courtesy of NIAID

Last year, herd immunity seemed like a comforting promise as researchers worked on dozens of COVID-19 vaccine candidates and a silver-lining to the rampant spread of the virus — the more people who got infected, the more natural immunity that would develop over time.

There are now dissenting opinions about how the term relates to the current pandemic and the role of vaccines in achieving it.

A Wall Street Journal op-ed recently opined that herd immunity is just around the corner, thanks mainly to natural immunity. Meanwhile, former FDA commissioner Dr. Scott Gottlieb and The Atlantic argued the U.S. might never reach herd immunity against SARS-CoV-2. Meanwhile, the consulting firm McKinsey suggests that herd immunity could be within reach in late 2…

FDA analysis finds J&J’s single-done COVID-19 vaccine is safe, effective

An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective.

The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA application for the vaccine developed by its Janssen unit on Feb. 4.

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

FDA analysis finds J&J’s single-done COVID-19 vaccine is safe, effective

An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective.

The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA application for the vaccine developed by its Janssen unit on Feb. 4.

According to the FDA briefing, the J&J vaccine candidate is 66% effective at preventing moderate and severe cases of COVID-19, falling within the administration’s standards for authorization, while it is also safe to use. The vaccine proved to be 85.4% effective in preventing severe cases while completely preventing hospitalizations and deaths. There were seven deaths in J&J’s Ensemble Phase 3 clinical trial, all of which occurred in the placebo group.

Should J&J’s vaccine candidate rec…

What made rapid mRNA COVID-19 vaccine development possible

Vials containing the Moderna COVID-19 vaccine. Image from Wikipedia.

A segment of the population is wary of COVID-19 vaccines. One of the main reasons why is the rapid pace at which they were developed.

But the mRNA vaccines FDA was able to authorize in late 2020 were years in the making, stressed Kizzmekia Corbett of the NIH at CDC’s National Forum on COVID-19 Vaccine virtual event.

The traditional vaccine development process, which typically spans years, was “shortened, but no integrity was lost,” Corbett said.

Scientists at the NIH have studied coronaviruses for several years, said Corbett, who leads a research team there focused on coronavirus vaccines.

One central factor driving the rapid development of mRNA COVID-19 vaccines was the collaboration between laboratories, institutions and companies across the globe.

“And then secondly, there was extensive work on MERS and other …