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Moderna starts testing its COVID-19 vaccine on kids

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (Nasdaq: MRNA) announced today that it has started dosing the first participants in its Phase 2/3 KidCOVE study evaluating its COVID-19 vaccine among children between the ages of 6 months and 12 years.

The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and HHS’s Biomedical Advanced Research and Development Authority (BARDA) are collaborating on the study, which marks the first time that a COVID-19 vaccine authorized in the U.S. is being tried out on very young children.

“It is humbling to know that 53 million doses have been administered to people in the U.S. We are encouraged by the primary analysis of the Phase 3 COVE study of mRNA-1273 in adults ages 18 and above and this pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age po…

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

Novavax (Gaithersburg, Md.) 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 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).

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

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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 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 story from our sister site, Drug Discovery & Development.

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…

Baxter to make Moderna COVID-19 vaccine in US

Baxter announced that its Baxter BioPharma Solutions business will make Moderna‘s COVID-19 vaccine at its fill/finish sterile manufacturing facilities in Bloomington, Ind.

The plan — announced yesterday — is for Baxter to make 60–90 million doses of the Moderna vaccine in 2021.

“We have seen a remarkable demonstration of scientific and health care expertise in the effort to develop vaccines for COVID-19,” said Marie Keeley, VP of Baxter BioPharma Solutions.

Get the full story on our sister site Pharmaceutical Processing World.

Baxter to make Moderna COVID-19 vaccine in US

Baxter announced that its Baxter BioPharma Solutions business will make Moderna‘s COVID-19 vaccine at its fill/finish sterile manufacturing facilities in Bloomington, Ind.

The plan — announced yesterday — is for Baxter to make 60–90 million doses of the Moderna vaccine in 2021.

“We have seen a remarkable demonstration of scientific and health care expertise in the effort to develop vaccines for COVID-19,” said Marie Keeley, VP of Baxter BioPharma Solutions.

“Baxter is honored to provide our deep expertise in vaccine manufacturing to help partners like Moderna bolster the supply of their vaccine,” Keeley said in a news release.

Baxter’s 600,000 ft2, 700-employee campus in Bloomington has capabilities and expertise in parenteral delivery systems and clinical and commercial vaccine manufacturing — including preventive and seasonal vaccines for global markets.

The major COVID-19 vaccine makers have been making a host of manufa…

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

Image courtesy of 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.

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

Moderna revenue soars in Q4 thanks to COVID-19 vaccine

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna posted mixed fourth-quarter results today with a larger-than-expected loss but beat the consensus forecast for revenue. The company boosted its outlook for the rest of the year, citing strong demand and maturing commercialization capabilities.

The Cambridge, Mass.-based vaccine developer reported revenue of $570.7 million for the three months ended Dec. 31, 2020. That figure was well ahead of the consensus estimate of $326.58 million. Revenue in the same period of 2019 was $14 million.

The company reported a loss of $272.5 million in its fourth quarter. That equated to a loss per share of –$0.69. Analysts had expected a loss of –$0.25. The company had a loss of $0.34 per share a year ago.

“2020 was a historic year for Moderna,” said the company’s CEO, Stéphane Bancel, in an earnings call. Beginning the year as “an early-stage development co…

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…