Study: Pfizer-BioNTech vaccine dramatically reduces risk of death from COVID-19

Recent real-world data from the Israel Ministry of Health found that unvaccinated individuals were 29 times more likely to die as a result of COVID-19 complications than those who received two doses of the BNT162b2 Pfizer-BioNTech vaccine. 

In addition, those who were unvaccinated were 44 times more likely to contract symptomatic COVID-19. 

The data also suggest that the vaccine prevents the spread of asymptomatic COVID-19 and is 94% effective against symptomatic disease. 

Researchers from the U.K. have also published a preprint that suggested that a single dose of the BNT162b2 vaccine provided a 43% risk of hospitalization and a 51% reduction in risk of death in individuals 70 or older. 

In addition, the BNT162b2 vaccine was 89% effective at least 14 days after the second vaccination. The U.K. study also found that a single dose of the vaccine resulted in an 85% reduction in the risk of death from COVID-19. 

The Israeli data came from Jan…

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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…

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

Image courtesy of 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.

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

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QAnon group targeting COVID-19 vaccines

QAnon, which supports far-right conspiracy theories, is ramping up its focus on COVID-19 vaccines. 

In particular, the group is framing COVID-19 vaccines as bioweapons developed by a coalition of Big Pharma and government officials. 

Pushed away from mainstream social media sites like Facebook, Twitter and YouTube, QAnon adherents have taken to the encrypted instant messaging platform Telegram and the dark web. There, they allege that COVID-19 vaccines are causing scores of deaths and health complications.

QAnon and other similarly-minded groups are spreading conspiracy theories aimed to “create resistance to both the Covid vaccine and various public health measures intended to combat the spread of Covid,” concluded a recent report from Rutgers and Network Contagion Research Institute. 

The unprecedented speed at which COVID-19 vaccines were developed followed by a chaotic mass vaccination campaign played a role in stoking such conspiracy theories…

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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…

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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…

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Why emergency authorization of COVID-19 therapies could pose 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.

Get the full…

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What are the most common COVID-19 vaccine side effects?

[Photo by Daniel Schludi on Unsplash]

Now that it has been nearly four months since the FDA authorized the first COVID-19 vaccine, a decent amount of safety information is available about the Pfizer-BioNTech vaccine.

CDC recently released a summary of adverse event data related to the Pfizer-BioNTech vaccine based on more than 5,000 entries to the Vaccine Adverse Event Reporting System collected from Dec. 14, 2020, to Jan. 13.

The summary also included data related to more than 1,000 recipients of the first dose of Moderna COVID-19 vaccine.

The entries make up only a minuscule fraction of the more than 90 million doses of COVID-19 vaccine that Americans have received to date.

A total of 93.7% of the reports related to the first dose of Pfizer-BioNTech vaccine were nonserious, although that figure dropped to 78.6% when it came to the second dose. For the Moderna vaccine, 81.2% of the event…

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How intranasal vaccines can confer immunity where it matters

Mucosa and relevant structures. [Image from Wikipedia]The COVID-19 vaccine landscape is gradually becoming more diverse. And it could grow more so, as several companies work on intranasal vaccines.

Intranasal vaccines offer potential advantages over traditional intramuscular vaccines. They can stimulate immunoglobulin A production, which can avert infection, as a recent Scientific American article noted.

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

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Why intranasal vaccines confer immunity where it matters

Mucosa and relevant structures. [Image from Wikipedia]

The COVID-19 vaccine landscape is gradually becoming more diverse. And it could grow more so, as several companies work on intranasal vaccines.

Intranasal vaccines offer potential advantages over traditional intramuscular vaccines. They can stimulate immunoglobulin A production, which can avert infection, as a recent Scientific American article noted.

“It’s not insignificant to go from a needle-based delivery to nasal delivery,” said Dr. C. Buddy Creech, who is the director of the Vanderbilt Vaccine Research Program.

Buddy Creech, MD. Photo by Joe Howell

The approach has several clear advantages. Intranasal vaccines would likely generate mucosal immunity, reducing the virus’s odds to take root in the respiratory tract.

And once pediatric COVID-19 vaccines are available…

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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…

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Canada authorizes J&J’s COVID-19 vaccine

Photo by Hermes Rivera on Unsplash

Canada is hoping to accelerate its mass-vaccination program with the authorization of Johnson & Johnson’s COVID-19 vaccine, which the FDA also recently authorized.

Canada has now authorized four vaccines.

Pfizer has also agreed to ramp up deliveries to the country.

By the end of June, Canada could have 36.5 million vaccine doses. The country’s population is 37.9 million.

Ontario, the most densely populated province, also announced that it would allow the first and second doses of the Pfizer-BioNTech and Moderna vaccines to be administered with an up to four-month interval between doses.

The J&J vaccine currently requires only a single dose, although the company is testing a two-dose regimen.

Because the U.S. isn’t currently allowing domestically produced vaccines to be exported, Canada has relied on Europe and Asia to provide vacci…

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