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NIH to study allergic reactions to COVID-19 mRNA vaccine

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Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines.

The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants who experienced a mild or moderate systemic allergic reaction to either the Pfizer/BioNTech or Moderna COVID-19 vaccines.

People who developed a severe allergic reaction to a first dose of a COVID-19 mRNA vaccine are not eligible to enroll.

According to a news release, participants will receive a second dose of the vaccine as inpatients under carefully controlled conditions at the National Institutes of Health’s Clinical Center in Bethesda, Maryland. NIAID’s Laboratory of Allergic Diseases’ Dr. Pamela A. Guerrerio…

Countries in need will have access to Moderna COVID-19 vaccine tech

Moderna (Nasdaq:MRNA) announced four new initiatives within a global public health strategy for advancing mRNA vaccines.

Cambridge, Massachusetts-based Moderna plans to expand its global public health portfolio, accelerate research in an effort to advance additional vaccines, expand its patent pledge to never enforce COVID-19 patents in the Gavi COVAX AMC for 92 low- and middle-income countries and establish Kenya as the location for its mRNA manufacturing facility.

Get the full story at our sister site, Pharmaceutical Processing World.

Countries in need will have access to Moderna COVID-19 vaccine tech

Moderna (Nasdaq:MRNA) announced four new initiatives within a global public health strategy for advancing mRNA vaccines.

Cambridge, Massachusetts-based Moderna plans to expand its global public health portfolio, accelerate research in an effort to advance additional vaccines, expand its patent pledge to never enforce COVID-19 patents in the Gavi COVAX AMC for 92 low- and middle-income countries and establish Kenya as the location for its mRNA manufacturing facility.

According to a news release, Moderna intends to expand its global public health portfolio to 15 vaccine programs targeting priority pathogens that threaten global health, advancing those vaccines into clinical studies by 2025. The company plans to prioritize development efforts against pathogens identified as persistent global health threats, including HIV, tuberculosis (TB) and malaria, neglected tropical diseases and the priority pathogens of the World Health Organization (WHO) and the Coalition f…

Johnson & Johnson inks agreement to have its COVID-19 vaccine manufactured in Africa

Johnson & Johnson (NYSE:JNJ) announced today that it completed an agreement for the manufacturing of its COVID-19 vaccine in Africa.

The landmark agreement, made between Johnson & Johnson’s Janssen Pharmaceuticals and South Africa-based Aspen SA Operations, allows for the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, with aims of increasing COVID-19 vaccination rates across the continent.

Get the full story at our sister site, Pharmaceutical Processing World.

Johnson & Johnson inks agreement to have its COVID-19 vaccine manufactured in Africa

Johnson & Johnson (NYSE:JNJ) announced today that it completed an agreement for the manufacturing of its COVID-19 vaccine in Africa.

The landmark agreement, made between Johnson & Johnson’s Janssen Pharmaceuticals and South Africa-based Aspen SA Operations, allows for the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, with aims of increasing COVID-19 vaccination rates across the continent.

According to a news release, only about 12% of people in Africa are fully vaccinated, which falls well short of the World Health Organization’s target of 70% population coverage for all countries. Johnson & Johnson has shipped more than 200 million vaccine doses to Africa through a combination of advance purchase agreements with the African Vaccine Acquisition Trust, South Africa and Gavi, the Vaccine Alliance, on behalf of the COVAX Facility, along with government donations.

The c…

Medicago and GSK win approval from Health Canada for adjuvanted plant-based COVID-19 vaccine

GlaxoSmith Kline (NYSE:GSK) and Sanofi (NYSE:SNY) recently announced their intent to seek regulatory authorization for an adjuvanted recombinant protein-based COVID-19 vaccine.

Now, GSK and its partner Medicago have received approval from Health Canada for another COVID-19 vaccine, which combines the former’s adjuvant technology with the latter’s plant-derived vaccine.

Known as Covifenz, the vaccine makes use of plant-based virus-like particles.

The Health Canada approval covers adults between the ages of 18 to 64.

The agency approved the Novavax COVID-19 vaccine last week.

GSK is also working with K Bioscience in South Korea on an adjuvanted COVID-19 vaccine and with CureVac on a next-generation mRNA vaccine.

“This first approval is an important milestone in our approach of pairing GSK’s well-established pandemic adjuvant with promising antigens to develop protein-based, refrigerator-stable COVID-19 vaccines to help protect peopl…

Moderna skyrockets on Street-beating Q4 driven by COVID-19 vaccine sales

Vials containing the Moderna COVID-19 vaccine sit on a table in preparation for vaccinations at Kadena Air Base, Japan, Jan. 4, 2021. As part of the DoD strategy for prioritizing, distributing and administering the COVID-19 vaccine, those providing direct medical care and emergency services will be prioritized to receive the vaccine at units based in Japan, including Kadena AB. (U.S. Air Force photo by Airman 1st Class Anna Nolte)

Moderna (NSDQ:MRNA) shares are on the rise on fourth-quarter results that came in ahead of the consensus forecast.

MRNA shares were up 11.7% at $161.51 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 1.1%.

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

Moderna skyrockets on Street-beating Q4 driven by COVID-19 vaccine sales

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

Moderna (NSDQ:MRNA) shares are on the rise on fourth-quarter results that came in ahead of the consensus forecast.

MRNA shares were up 11.7% at $161.51 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 1.1%.

The Cambridge, Massachusetts-based company posted profits of $4.9 billion, or $11.29 per share, on sales of $7.2 billion for the three months ended Dec. 31, 2021, for a massive bottom-line gain from losses of $272 million in this period last year on sales growth of more than 12 times the revenues produced in the fourth quarter of 2020 ($571 million).

Moderna’s earnings per share of $11.29 came in $1.39 ahead of expectations on Wall Street, where analysts were looking for sales of $6.8 billion.

Product sale…

Sanofi and GSK aim to commercialize COVID-19 vaccine

In the U.S., Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) continue to dominate the COVID-19 landscape while demand for Johnson & Johnson’s (NYSE:JNJ) vaccine remains limited.

Now, Sanofi (NASDAQ:SNY) and GSK (NYSE:GSK) are preparing to get into the game by preparing their regulatory submissions for their COVID-19 vaccine. The companies are currently communicating with the FDA and European Medicines Agency (EMA).

In a Phase 3 efficacy trial, two doses of the vaccine in seronegative individuals were 100% effective against severe COVID-19 disease and hospitalization. Protection against moderate or severe COVID-19 was 75%, while protection against symptomatic COVID-19 was 57.9%.

A booster dose of the vaccine increased neutralizing antibodies 18- to 30-fold in recipients of mRNA and adenovirus vaccines.

The companies note that the research was carried out while challenging variants of concern were circulating. “No other global Phase 3 efficacy study…

FDA reportedly mulling authorizing fourth COVID-19 vaccine dose

[Image courtesy of Wikipedia]

Officials at the Food and Drug Administration are considering potentially authorizing an additional booster of the COVID-19 vaccines from Moderna (NASDAQ:MRNA) as well as Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), according to the Wall Street Journal.

At present, individuals 12 and older who are moderately or severely immunocompromised are eligible for four COVID-19 vaccine doses.

Before the FDA allows the broader public to obtain an additional dose, the agency would require data demonstrating the ability of a fourth dose to boost immunity.

At present, however, it remains unclear whether the agency would recommend first-generation vaccines or recommend a variant-specific version.

Pfizer, BioNTech and Moderna are working on omicron-based boosters.

CDC currently recommends all individuals who are at least 12 to obtain three doses of mRNA COVID-19 vaccine…

Pfizer-BioNTech omicron-based vaccine may be delayed

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have launched a clinical trial to test an omicron-specific version of their COVID-19 vaccine.

The two companies initially vowed to launch the updated vaccine by the end of March, but that goal may shift depending on the volume of clinical data regulators demand, according to BioNTech.

In the meantime, a number of countries have begun administering a fourth COVID-19 vaccine dose to immunocompromised individuals. In addition, Israel and Denmark have started offering a fourth dose to the public.

The European Medicines Agency (EMA) has stated it wants to see data showing that updated vaccines lead to higher neutralizing antibody levels than first-generation vaccines while potentially bolstering the protection against emerging variants.

Moderna is also working on an omicron-specific vaccine, but it won’t likely be available until August.

People who don’t get COVID-19 could provide clues for next-gen vaccines

SARS-CoV-2 image courtesy of Wikimedia Commons

A controversial SARS-CoV-2 challenge study involving 36 volunteers found that 47% of individuals did not develop COVID-19. The volunteers were unvaccinated and had no evidence of prior infection with SARS-CoV-2.

The study, whose results were recently published in a pre-print, could potentially point to new vaccine targets or inspire future COVID-19 drug research.

“This study has already generated intriguing insights into the timeline of infection, particularly in the early phase,” said Dr. Doug Brown, chief executive of the British Society for Immunology, in a statement. “In the longer term, the hope is that these findings will now open up a new research avenue to develop a platform that will allow us to speed up the development of new vaccines, antivirals and diagnostics against COVID-19.”

There are a variety of potential explanations why the volu…