COVID-19 vaccine trial Archives - Page 8 of 13

Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2

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Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine.

Speaking during the company’s first-quarter earnings call yesterday, which was transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is currently available to Americans 16 years of age and older through FDA emergency use authorization (EUA).

Bourla said the company is submitting a Biologics License Application to the FDA in search of full approval for the vaccine in individuals 16 years of age and older and plans to submit for EUA for two cohorts — children between age 2-5 and children between age 5-11 — in September 2021.

The company is awaiting a response from the FDA regarding its application for expanded EUA that would ext…

FDA could soon authorize Pfizer COVID-19 vaccine for younger adolescents

The COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) appears to be on the cusp of winning regulatory authorization for use in adolescents between the ages of 12 and 15, according to several media reports. FDA has authorized the vaccine for people aged 16 and up.

In March, Pfizer submitted clinical trial results to FDA, suggesting the efficacy of the vaccine was 100% for adolescents aged 12 to 15 based on a trial involving more than 2,000 participants. The reactogenicity of the vaccine in younger adolescents was also favorable.

The European Medicines Agency is also considering making the vaccine available to younger adolescents.

The news comes as vaccination rates in the U.S. fall while Europe’s vaccination efforts are picking up pace after months of sputtering.

In the U.S., the availability of the vaccine to children 12 and older would enable widespread vaccination before the beginning of the next school year.

Pfizer and Bio…

Pfizer and BioNTech seek EMA nod for younger adolescents

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After announcing that its vaccine was 100% efficacious in a Phase 3 trial involving adolescents aged 12 to 15, Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) are seeking E.U. authorization to distribute the vaccine to that age group.

BioNTech’s CEO, Uğur Şahin, estimated that the vaccine would be available to early adolescents in 27 European countries starting in June.

The companies requested in early April that FDA lower the vaccine eligibility from 16 to 12 years of age.

Janet Woodcock, FDA’s acting commissioner, vowed to review the request “as expeditiously as possible using our thorough and science-based approach” but declined to estimate how long it would take to do so.

BioNTech and its partner Pfizer are currently overseeing vaccine clinical trials for children as young as six months old.

The companies also plan on asking other international regu…

Study: Single dose of Pfizer or AstraZeneca COVID-19 vaccine cuts infection risk by 65%

[Photo by Daniel Schludi on Unsplash]

One dose of vaccine from Pfizer (NYSE:PFE) or AstraZeneca (LON:AZN) leads to a substantial reduction in infection risk in adults, according to a recent study published in BMJ.

The study organizers found that recipients of a single dose of either vaccine led to a 57% reduction in asymptomatic infections and a 74% drop in symptomatic disease at least 21 days after vaccination. The overall risk reduction was thus 65%.

A second dose of the vaccine from Pfizer and its partner BioNTech (NSDQ:BNTX) reduced the risk of infection by 70% in the study. There was insufficient data to assess the efficacy of the AstraZeneca vaccine after the second dose.

The researchers concluded that when vaccine supplies are limited, health systems should prioritize vaccinating those who have not yet been infected with COVID-19 while prioritizing giving second doses to those 60 and o…

Why demand for J&J and AstraZeneca COVID-19 vaccines remains unclear

This 2020 image shows a vial of J&J vaccine when it was investigational. Image from Johnson & Johnson.

After the European Medicines Agency determined that the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, the company announced that it would unfreeze its European vaccinate rollout. But assessing demand for the J&J and AstraZeneca vaccines remains difficult. The possible link to rare blood clots could elevate the role of vaccines from Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and others.

The European Medicines Agency (EMA) did, however, advise that the vaccine bear a warning describing a risk of rare blood clots.

Although the J&J vaccine had been authorized in the E.U., nations there have not yet used it. After U.S. authorities paused the use of the vaccine, Johnson & Johnson decided to suspend the distribution of the product voluntarily.

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mRNA vaccine led to shingles in a handful of immunocompromised patients

Electron micrograph of the varicella-zoster virus. Image courtesy of CDC.

A group of researchers in Israel has concluded that a mRNA-based vaccine could activate herpes zoster (shingles) in a limited number of people with rheumatic diseases.

The viral infection, which can cause a painful rash, is caused by the varicella-zoster virus, which is also responsible for chickenpox.

In a study focusing on individuals with autoimmune inflammatory rheumatic diseases (AIRD), researchers at the Tel Aviv Sourasky Medical Center and Carmel Medical Center in Haifa followed 491 patients and 99 controls. A total of six patients with AIIRD, or 1.2%, had a reactivation of herpes zoster after vaccination with the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

No patients in the control arm developed shingles in the study published in Rheumatology.

The researchers acknowledged that the st…

J&J reportedly asked COVID-19 vaccine developers to study blood clot risks

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Johnson & Johnson (NYSE:JNJ) privately contacted other COVID-19 vaccine makers last week to gauge their interest in studying blood clot risks, according to a Wall Street Journal report. Specifically, the company asked whether its rivals — AstraZeneca, Moderna and Pfizer— had new information about blood clots following vaccination and if they were interested in forming an external panel to examine the issue, according to the article citing anonymous sources.

None of the four companies have confirmed nor denied the report.

J&J researchers did state in NEJM that there is insufficient evidence to link six cases of cerebral venous sinus thrombosis (CVST) paired with low platelet counts to the company’s COVID-19 vaccine. Approximately seven million people in the U.S. have received the vaccine.

AstraZeneca (LON:AZN) is said to have been interested in allying wit…

A quick history of the tech behind J&J, AstraZeneca’s COVID-19 vaccines

Transmission electron micrograph of two Adenovirus particles. Image courtesy of Wikipedia.

After regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), some regulatory authorities wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events.

Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s in early experiments with the platform. But the safety of the platform has improved as genetic engineering has advanced.

The history of using viruses as vectors dates back to the mid-1970s when scientists Dr. J. Michael Bishop and Dr. Harold Varmus demonstrated that gamma-retroviruses could acquire cellular genes.

Researchers began creating adenoviral vectors in the 1980s, testing replication-de…

Annual COVID-19 vaccines likely, according to Pfizer CEO

The public may require annual vaccines to protect against SARS-CoV-2, Pfizer (NYSE:PFE) CEO Albert Bourla said today.

“It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said in a CNBC interview.

While the details of Pfizer-BioNTech boosters are not yet clear, COVID-19 boosters will likely be based on an mRNA platform.

Adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson are currently in limited use, given concerns that they could cause rare but serious blood clotting problems.

The mRNA vaccines from Moderna and Pfizer/BioNTech also have a head start, and U.S. officials expect 600 million doses of the vaccines to be delivered by the end of July.

It will be “a stretch for adenoviral-vector vaccines to have any material uptake,” in the U.S., said Navin Jacob, a senior equity research analyst at UBS. “And you can’t really give boosters with the adenoviral-vector vaccin…

Researcher: Neuroinflammation may be behind tinnitus reports in some COVID-19 vaccine recipients

Photo by Mark Paton on Unsplash

Peripheral cytokines from COVID-19 vaccines could cause or exacerbate tinnitus, or ringing in the ears, theorized Shaowen Bao, an associate professor of neuroscience and physiology at the University of Arizona.

Recent articles on Drug Discovery & Development on the possible link between tinnitus and COVID-19 vaccines have attracted hundreds of comments.

Some 0.65% of COVID-19 vaccine recipients who filed reports in CDC’s Vaccine Adverse Event Reporting System (VAERS) reported the issue. Although VAERS is not exhaustive, those 369 reports out of a total of 56,722 VAERS entries represent a tiny fraction of 190 million COVID-19 vaccine doses that have been administered in the U.S. to date.

Six volunteers in J&J’s Phase 3 trial for its COVID-19 vaccine complained of tinnitus. FDA, however, concluded there was insufficient evidence to link the issue t…

6 assumptions about COVID-19 vaccines as AstraZeneca and J&J face safety scrutiny

[Photo by Daniel Schludi on Unsplash]

With COVID-19 cases surging in many parts of the world, the need is high for multiple vaccines to slow the virus.

But the fate of adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson has become murky after a limited number of people receiving those vaccines have developed blood clot disorders.

Officials in both the EU and the U.S. suspect there could be a link between adenovirus-based COVID-1 vaccines and blood clotting problems such as cerebral venous sinus thrombosis. Authorities in both countries have either temporarily halted or constrained the use of adenovirus vaccines.

Russia’s Sputnik V and China’s CanSino Biologics also have COVID-19 vaccines based on an adenovirus platform.

1. The blood clotting problems seems rare but more common in women

Even though blood clotting problems have gotten a substantial amount of att…

EMA begins investigation of J&J COVID-19 vaccine’s blot clotting potential

The European Medicines Agency (EMA) announced that it is beginning a review of blood clots appearing in a handful of recipients of the Johnson & Johnson COVID-19 vaccine.

EMA recently concluded that blood clots associated with low blood platelet levels were a “very rare” side effect of Vaxzevria, the vaccine from AstraZeneca.

Four recipients of the Johnson & Johnson vaccine have had such blood clotting events. One of those individuals has died.

A Johnson & Johnson summary of the Ad26.COV2.S vaccine clinical trial cited a “numerical imbalance” for deep vein thrombosis (DVT) and pulmonary embolism (PE) between vaccine and placebo recipients. In the vaccine arm, there were five cases of DVT and four cases of PE. By contrast, there were two DVT reports and one of PE in the study’s placebo arm.

The company has stressed that it has found no causal relationship between the rare blood clotting events and its vaccine.

European regul…