COVID-19 vaccine Archives - Page 32 of 38

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 J&J’s COVID-19 vaccine linked to tinnitus?

In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears.

In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer.

No placebo recipients developed the condition.

Get the full story from Drug Discovery & Development.

Could a third vaccine shot better protect against COVID-19 variants?

[Photo by Daniel Schludi on Unsplash]

Pfizer/BioNTech and Moderna are testing whether a third dose of their COVID-19 vaccines could better protect against new virus variants.

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that participants from their Phase 1 study will be offered the opportunity to receive a 30 µg booster of the current vaccine 6 to 12 months after receiving their initial two doses. The two companies are also in discussions with regulatory authorities including the U.S. FDA and European Medicines Agency about a registration-enabled clinical study of a vaccine with a modified mRNA sequence geared toward the South African variant.

“While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine, we are taking multiple steps to act decisively and be ready in case a strain becomes resistant to the protection afforded by t…

Is COVID-19 herd immunity elusive or within reach?

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.

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

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 …

GSK, Sanofi launch new COVID-19 vaccine study for protein-based vaccine

Sanofi (NYSE:SNY) and Glaxo Smith Kline (NYSE:GSK) are moving forward with their development plans of a COVID-19 vaccine.

In December, the two companies announced that their vaccine development efforts had been delayed after the product failed to mount a robust immune response in older adults.

The two companies believe the setback resulted from an insufficient amount of the antigen in the vaccine. They have since revised the formulation and have launched a Phase 2 study to test the adjuvanted recombinant protein-based COVID-19 vaccine candidate.

If the study meets its primary endpoints, the companies will launch a Phase 3 trial in the second quarter of the year with authorization potentially following in the fourth quarter of the year.

“We are confident that our vaccine candidate has strong potential and we are very encouraged by the latest preclinical data,’ said Thomas Triomphe, executive vice president and head of Sanofi Pasteur, in a statement…

FDA prioritizes quick trials for variant-specific COVID-19 vaccines

FDA has released updated guidance detailing its plans to streamline authorization of COVID-19 vaccines adapted to more-infectious variants, such as the U.K. variant B.1.1.7, which is now present in dozens of states.

FDA’s guidance would require such companies to launch small clinical studies similar to those needed for annual flu vaccines.

It also encourages sponsors to test modified vaccines in unvaccinated as well as previously-vaccinated individuals.

“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement.

Recent data suggest that variant B.1.429, initially found in California, is also more infectious than earlier lineages.

Complicating matters further, B.1.1.7 and B.1.429 have merged in a recombination process to create a new hybrid. Other kno…

FDA issues guidelines to address COVID-19 variants

SARS-CoV-2 image from Wikipedia

The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19.

Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing remain in place and vaccines are being distributed.

“The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” acting FDA Commissioner Dr. Janet Woodcock said in a news release. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this …

5 takeaways from the latest White House COVID-19 response team briefing

Today, the White House COVID-19 response team held a press briefing to discuss a range of themes. Andy Slavitt, Senior White House advisor, share information on the current pace of vaccination. CDC Director Dr. Rochelle Walensky shared information on the current spread of COVID-19 and its impact on U.S. life expectancy. Dr. Anthony Fauci, the nation’s top infectious disease expert, was on hand to discuss the potential vaccination of children. Here are five highlights from the briefing:

1. Freezing weather has curbed COVID-19 vaccine distribution

All 50 states have been affected by COVID-19 vaccine shortages stemming from severe weather afflicting much of the U.S. “We have a backlog of about 6 million doses,” said Andy Slavitt, Senior White House advisor, in a press briefing.

U.S. vaccine distribution partners FedEx, UPS and McKesson have struggled to package and ship vaccine kits and related supplies. Many of the firm’s workers have struggled with road cl…