vaccine for new born :: Article CreatorFDA Approves Moderna's RSV Vaccine, Its Second Licensed Product
The Food and Drug Administration on Friday approved Moderna's vaccine to protect older adults against respiratory syncytial virus, or RSV, making this the company's second licensed product.
The Moderna RSV vaccine, which will be marketed under the name mResvia, was approved for adults 60 and older. It is made using the same messenger RNA platform as Moderna's other licensed product, its Covid-19 vaccine Spikevax.
"The FDA approval of our second product, mResvia, builds on the strength and versatility of our mRNA platform," Moderna CEO Stéphane Bancel said in a statement.
RSV can be contracted at any age, but the infection is more likely to trigger severe illness among infants and the elderly. The Centers for Disease Control and Prevention estimates that between 60,000 and 160,000 adults aged 65 and older are hospitalized in an average year for RSV and between 6,000 and 10,000 die from the infection.
The Moderna vaccine arrives on the market a year after two competitors, GSK's Arexvy, and Pfizer's Abrysvo, which were both approved for the same age group. (Pfizer's vaccine has a second approval for pregnant people as well.)
But Moderna said its vaccine is the only one of the three to be packaged in a prefilled syringe, which it argues saves time and cuts the risk of administration errors for pharmacists and other health professionals who administer vaccines.
In a pivotal Phase 3 trial involving nearly 37,000 people in 22 countries, mResvia was shown to have a vaccine efficacy of 83.7% against lower respiratory tract disease caused by RSV.
The company said a follow-up analysis of the primary endpoint was performed during the FDA review; it included cases that started before the primary analysis cut-off date but that were not confirmed until afterward. Those results were similar to the primary analysis, showing a vaccine efficacy of 78.7%, which was not statistically different from the earlier result.
Moderna said there were no serious safety concerns identified during the clinical trials, with injection site pain, fatigue, headache, and muscle and joint pain being the most commonly reported side effects. Importantly, there were no reports of Guillain-Barré syndrome, a form of progressive paralysis from which people generally recover. Both Pfizer and GSK reported cases of GBS in their clinical trials, findings that concerned the expert panel that helps the CDC set recommendations on how licensed vaccines should be used.
The Advisory Committee on Immunization Practices, or ACIP, recommended last year that adults 60 and older could get one of the RSV vaccines, but should discuss the pros and cons with a medical practitioner, forgoing a more emphatic — and perhaps market-boosting — recommendation urging all adults in the eligible age group to get one of the vaccines. An analysis the CDC published this week supported the cause for concern, noting that the rate of reported GBS cases per million doses of vaccine administered was 5.0 cases for the Pfizer product and 1.5 for the GSK. Those rates were both higher than what was seen with Covid vaccines, which were not linked to an increased risk of GBS.
That potential advantage for the Moderna vaccine may be counterbalanced by concerns about the durability of the protection it triggers.
Moderna's statement said follow-up of participants from its trial showed protection lasted over 8.6 months at least. (When a vaccine is new, it takes time to determine how durable its protection is.) But an analysis issued in February by market analysts TD Cowen questioned if the protection conferred by the Moderna shot wanes more quickly than the protection conferred by its competitors. Both the GSK and Pfizer vaccines appear to protect for at least two cold-and-flu seasons.
Before the Moderna vaccine can be put into use, it must receive a recommendation from the CDC, which only issues advice on how a vaccine should be used after the vaccine has been studied and voted on by the ACIP. That group next meets in late June. Health insurance companies use the CDC's recommendation to set their coverage policies.
As Moderna waits to clear the final hurdle to get its RSV vaccine into pharmacies, both GSK and Pfizer have already applied to the FDA for license extensions, arguing the vaccines should be offered to adults under the age of 60 who are at high risk of severe illness from RSV infection.
GSK, which used a priority review voucher to speed its application through the approval process, expects to hear whether Arexvy can be targeted at people 50 and older by June 7. Pfizer is seeking a more ambitious license extension, applying to be able to market Abrysvo to adults 18 and older who are at high risk from RSV.
In the first year of use of these vaccines, the CDC estimates that 24.4% of people aged 60 and older received an RSV vaccine.
US Approves Moderna's RSV Vaccine For Older Adults
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The US Food and Drug Administration on Friday approved Moderna's respiratory syncytial virus (RSV) vaccine for older adults -- marking the first time any mRNA shot has been authorized against a disease other than Covid-19.
RSV is a highly contagious seasonal virus that can cause severe symptoms in infants and the elderly that causes around 60,000–160,000 hospitalizations and 6,000–10,000 deaths per year in the United States, according to official estimates.
There are already two approved vaccines for those aged 60 and over, by GSK and Pfizer, both of which have been on the market since last year.
"The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform," said Stephane Bancel, chief executive officer of the US biotech firm, in a statement.
"mRESVIA protects older adults from the severe outcomes of RSV infection," he continued, adding that unlike its competitors, Moderna's shot was available in pre-filled syringes to reduce the risk of clinical errors.
GSK and Pfizer's vaccines rely on traditional recombinant protein technology, introducing a pathogen component to the immune system to trigger a response.
In contrast, Moderna's vaccine utilizes cutting-edge messenger RNA (mRNA) technology, instructing the body to produce a unique protein that stimulates an immune response, teaching it to defend against the infection.
The approval was based on positive trial data published in the New England Journal of Medicine in December.
A global study of approximately 37,000 people aged 60 and older found the shot had an efficacy of 83.7 percent against lower respiratory tract disease -- meaning when an RSV becomes more severe and can cause pneumonia, bronchitis, shortness of breath and more.
There were no serious safety concerns, with common side effects including pain at the injection site, fatigue, headache, body aches and joint stiffness.
Moderna said it expected the vaccines to be available for the 2024-2025 RSV season, and had filed for approval with regulators around the world.
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The Barron's news department was not involved in the creation of the content above. This article was produced by AFP. For more information go to AFP.Com.© Agence France-Presse
VDEC To Support A GBS Vaccine To Prevent Newborn Deaths
The vaccine development and evaluation centre (VDEC) facilitates the development and evaluation of new vaccines and therapeutics.
VDEC's work includes vaccine discovery and surveillance. The Vaccine Assay and Immune Response team within VDEC provides world class scientific expertise and regulated facilities to enable the classification of diseases, pathogens and their mechanisms of action. They also provide continued national surveillance after the release of vaccines.
They have recently been supporting the creation of a maternal vaccine for Group B Streptococcus (GBS).
Target: GBS is the leading cause of vaccine-preventable infections in newborns in the developed world, and a significant cause of newborn infections and stillbirths worldwide. As such, GBS is a leading driver of antibiotic use in neonatal settings, and antimicrobial resistance is increasing.
To reduce early-onset disease (usually within the first 48 hours of life) many countries have introduced screening for GBS in pregnancy. Culture positive mothers are then given intravenous antibiotics in childbirth to protect both the mother and the infant. This has dramatically increased the use of antibiotics in childbirth. In some countries over 50% of childbirths now involve intravenous antibiotic use.
Aims: A maternal vaccine for GBS which protects infants from both early and late onset disease (for which intrapartum antibiotics have no effect) will have a positive impact on infant mortality and morbidity. It will also lead to a sharp reduction in the use of antibiotics in neonatal units worldwide.
Issues: Reducing antibiotic use in newborns will allow the development of appropriate commensal gut bacteria. This enables them to digest milk and reduces the risk of antimicrobial resistance.
Options: The UKHSA Pathogen Immunology Group at Porton Down had previously been part of the GASTON consortium. This is an international consortium to develop standardised correlates of protection to allow the evaluation of new GBS vaccines and enable licensure of the leading candidates.
UKHSA Porton successfully developed a 'Gold Standard' opsonophagocytic killing assay (OPKA) and led a global interlaboratory study of the OPKA in public health, academic and industry labs. The assay was shown to be highly sensitive and reproducible in different laboratories, and standard GBS test strains have been selected by UKHSA and made available worldwide.
In 2022 to 2023, follow-on funding was awarded by the Bill and Melinda Gates Foundation (BMGF) to develop a higher-throughput version of the OPKA suitable for phase II/III clinical trials and to provide international reference serum samples with defined units of opsonophagocytic activity. The high throughput OPKA is required as the current assay method is very labour-intensive which limits the number of sera that can be analysed in large vaccine studies.
Licensure of a GBS vaccine will: Prevent the deaths of tens of thousands of newborns worldwide: reduce the need for antibiotic treatment in disease cases; reduce the need for intrapartum antibiotics during childbirth.
Future work: As part of this project, the team has also developed an OPKA for GBS serotype VII, which will be used in a follow-up PATH-funded phase I/II clinical study of a novel 6-valent GBS vaccine currently being developed.
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