Myth: The Fda Authorized Covid
While its true that vaccine development can take a lot longer for some diseases we still dont have an effective vaccine for HIV, for instance it can happen much more quickly for other illnesses.
For example, we understand the vaccine technology very well for influenza, said Dr. Benjamin Bates, a professor of health communication at Ohio University, which is how were able to develop new vaccines to different strains of influenza annually. That helps expedite the process.
In the case of the SARS-CoV-2 virus that causes COVID-19, Bates said, we were fortunate because scientists began studying SARS viruses extensively after the SARS and MERS outbreaks of the early 2000s.
By the time COVID-19 was identified, we had done a lot of the homework over the previous two decades, he said. That previous knowledge allowed manufacturers to quickly develop laboratory and computer modeling tests for potential vaccines. It also helped them to perform early tests for safety and efficacy in real people to be ready to meet the FDAs standards for authorization and approval.
Dr. Leana Wen, an emergency physician and public health professor at George Washington University, said that no shortcuts were taken in the research or authorization process of any of the COVID-19 vaccines and that getting them out to Americans more quickly though the emergency use authorization saved countless lives.
Flu Shots For Seniors
Sinead Morris, Ph.D., recently presented to the CDC’s ACIP: Recommending that enhanced seasonal influenza vaccines in adults aged 65 and older could have wide-ranging impacts on the influenza burden. And Lisa Grohskopf, Influenza Division, CDC, presented: Influenza Vaccines for Older Adults: GRADE Summary.
Fda Approves Seasonal Flu Vaccine
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WASHINGTON – The Food and Drug Administration approved the ordinary seasonal flu vaccine on Monday and said Americans should plan to be vaccinated.
A technician illuminates eggs during a simulation of the vaccine production process in a file photo. REUTERS/Tim Shaffer
Vaccines against seasonal flu usually become available in September or October and flu experts say it is worthwhile to be immunized as late as January, as the U.S. influenza season usually peaks in February.
This year will be different — the new H1N1 swine flu virus has circulated all summer and companies are working to make a separate vaccine against the pandemic strain.
The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization on June 11, 2009, the FDA said in a statement.
Although this years seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine.
The U.S. government says a swine flu vaccine should be available by mid-October and it likely will be offered to younger adults and older children, with healthcare workers first in line so they can stay healthy to vaccinate everyone else.
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Myths About What It Means For A Vaccine To Be ‘fda Approved’
A recurring sentiment among some in the vaccine-hesitant community is a desire to wait to receive any of the three available COVID-19 vaccines until they have been officially approved by the Food and Drug Administration. And while the FDA hasauthorized the Pfizer, Moderna and Johnson & Johnson vaccines and is expected to also approve each one in turn for many people, the difference between authorized and approved has been confusing.
To combat COVID-19, the FDA used a measure known as an emergency use authorization to speed up the process by which safe and effective vaccines could begin being distributed across the country. Such a measure required only two months of safety and efficacy data from clinical trials in this case, compared with the minimum of six months manufacturers usually have to wait before applying for FDA approval .
And while this process has been used by the FDA before the measure has existed for decades its arguably never been followed by the public so closely. That has led to some misunderstandings about what it actually means for a product or procedure to be FDA approved.
Here are a few myths circulating about FDA approval and why you shouldnt let the process stand in the way of getting vaccinated:
Fda Approves Flu Vaccine For Children As Young As 6 Months
Seqiruss FLUCELVAX® cell-based quadrivalent influenza vaccine has been approved to expand the age indication to children as young as 6 months of age by the US Food and Drug Administration.
The US Food and Drug Administration has approved the FLUCELVAX® cell-based quadrivalent influenza vaccine for an expanded age indication for children as young as 6 months of age.1 The vaccine is now indicated for any patient who is eligible to receive an influenza vaccine in the United States.
The approval was based on phase 3 clinical trial data that showed the vaccine was as immunogenic and safe as the standard quadrivalent seasonal influenza vaccine in children 6 months of age to < 4 years during the 2019 to 2020 annual influenza season. In the trial 2414 children were randomized to receive either FLUCELVAX® or the standard quadrivalent vaccine.
Depending on vaccination history, a child received either 1 or 2 vaccine doses. Following immunization, participants received at least 180 days of follow-up and noninferiority of FLUCELVAX® was determined. The safety of the FLUCELVAX® vaccine was comparable to the standard vaccine and common adverse events included tenderness, irritability, and erythema at the site of injection. Complete data from the clinical trial was presented at the Pediatric Academic Society virtual Annual Meeting earlier in 2021.
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Annual Update Of Seasonal Influenza Vaccines
To maintain effectiveness, the composition of seasonal influenza vaccines must be reviewed and updated periodically to include the most current HA antigens expressed by circulating influenza wildtype viruses. This is a complex, lengthy process that requires extensive collaboration among influenza manufacturers, vaccine regulators, and global public health laboratories. The process begins with the recommendations, coordinated globally by the World Health Organization , for the virus strains to be included in the vaccine.4 The WHO recommendations for the Northern Hemisphere, which are based on recent global surveillance data available each February, provide a guide to national public health authorities and vaccine manufacturers for the development and production of influenza vaccines for the following winter influenza season. However, as noted in the WHO recommendations, it is the responsibility of each national regulatory authority to approve the composition and formulation of the vaccines used in that country. Each year, soon after the WHO Northern Hemisphere vaccine recommendations are finalized, the FDA convenes its Vaccines and Related Biological Products Advisory Committee , typically in late February or early March, to recommend the virus strains that should be included in FDAlicensed influenza vaccines for the next winter influenza season in the United States.
Fda Oks Novartis Flu Vaccine
|Novartis vaccine production at Holly Springs facility.|
North Carolinas reputation as Vaccine Central got an official boost from federal regulators Tuesday with marketing approval for Novartis flu vaccine using the highly efficient process of cell culture.
The United States Food and Drug Administration put its blessing on the innovative product named Flucelvax, making it the first influenza vaccine of its kind available in the U.S.
The most unique feature of the product is the fact that its grown in dog cells rather than fertilized chicken eggs. In the event of a flu pandemic, at least 25 percent of the nations vaccine protection can be quickly produced at the $1 billion, 167-acre, six-building Novartis Holly Springs campus.
|Flucelvax, Novartis’ newly approved flu vaccine for the U.S. market|
The U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority gave Novartis a $289 million contract to support the design, construction, validation and licensing of the plant.
The resulting facility, 25 miles south of Research Triangle Park, is the largest biomanufacturing plant in the U.S. It now employs some 500 people, more than 85 percent of whom were drawn from North Carolinas well-trained workforce. The workers occupy more than 430,000 square feet of manufacturing, laboratory and office space.
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Influenza Vaccines And How They Are Made
Influenza vaccine works by triggering your immune system to produce antibodies that help the body prevent the flu.
Most of the U.S. influenza vaccine supply is made using an egg-based production process. In this method of making influenza vaccines, manufacturers use fertilized eggs to grow flu viruses. After about six months of laboratory work and manufacturing, those viruses are incorporated into that seasons flu vaccine. While this method produces safe and effective vaccines, FDA, HHS, and manufacturers have been working on different technologies to increase the influenza vaccine supply, making sure to still maintain safety and effectiveness. Some technologies have the potential to produce these vaccines faster and less labor-intensively.
For example, more recent approvals include influenza vaccines that do not use an egg-based production process for manufacturing. In addition, quadrivalent vaccines, which protect against two influenza A strains and two influenza B strains, have been available for several years. Quadrivalent vaccines provide protection against the two lineages of influenza B strains, both of which circulate each flu season. This is important, particularly for preschool and school-age children who get Influenza B more often than adults do. Influenza B also causes more complications and fatalities in children than adults.
A Flu Vaccine Is The Best Prevention
Flu seasons and their severity are unpredictable. Annual vaccination is the best way to prevent influenza in people ages 6 months and older.
An annual vaccination to prevent flu is the best way to reduce the risk of getting the flu and spreading it to others. When more people get vaccinated, it is less likely that the flu viruses will spread through a community.
The vaccine typically changes each year and contains the four flu virus strains that are expected to circulate in the U.S. during the upcoming flu season. The effectiveness of influenza vaccines varies depending on several factors, such as the age and health of the recipient, the types of circulating influenza viruses, and the degree of similarity between circulating viruses and those included in the vaccine.
The task of producing a new vaccine for the next flu season starts well before the current season ends. For the FDA, its a year-round initiative.
The flu vaccine will trigger your immune system to produce antibodies to protect against influenza disease it will not make you sick with the flu. It can take about two weeks after vaccination for antibodies to develop in the body, which is an important reason to get your flu vaccine early, before flu activity starts.
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How Cdc Monitors Vaccine Safety
CDC and FDA monitor the safety of vaccines after they are approved or authorized. If a problem is found with a vaccine, CDC and FDA will inform health officials, health care providers, and the public.
CDC uses 3 systems to monitor vaccine safety:
- The Vaccine Adverse Event Reporting System : an early warning system, co-managed by CDC and FDA, to monitor for potential vaccine safety problems. Anyone can report possible vaccine side effects to VAERS.
- The Vaccine Safety Datalink : a collaboration between CDC and 9 health care organizations that conducts vaccine safety monitoring and research.
- The Clinical Immunization Safety Assessment Project: a partnership between CDC and several medical research centers that provides expert consultation and conducts clinical research on vaccine-associated health risks.
Fda Approves Flu Vaccine For Coming Season
WASHINGTON — The Food and Drug Administration said Monday it has approved the new flu vaccine for the season beginning this year.
Each year the FDA works with other federal agencies and global health experts to design a vaccine to protect against the three viral strains most likely to cause the flu. This year’s flu shot will be a duplicate of last year’s because the same flu strains are still circulating.
The vaccine will be manufactured by six companies: GlaxoSmithKline, CSL Limited, ID Biomedical Corp., Medimmune Vaccines, Novartis and Sanofi.
Between 5 percent and 20 percent of Americans get the flu each year, leading to 200,000 hospitalizations, according to Centers for Disease Control and Prevention.
Last year, the CDC began recommending an annual flu vaccination for everyone except babies younger than 6 months and those with unusual allergies and medical conditions. That recommendation helped boost vaccination rates, along with the appearance in 2009 of swine flu, which was more dangerous than other strains to young people.
The CDC plans to buy about 18 million of the 2011-2012 doses, primarily for government vaccine programs for children.
First published on July 18, 2011 / 10:54 AM
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Other Methods Of Manufacture
Methods of vaccine generation that bypass the need for eggs include the construction of influenza virus-like particles . VLP resemble viruses, but there is no need for inactivation, as they do not include viral coding elements, but merely present antigens in a similar manner to a virion. Some methods of producing VLP include cultures of Spodoptera frugiperdaSf9 insect cells and plant-based vaccine production . There is evidence that some VLPs elicit antibodies that recognize a broader panel of antigenically distinct viral isolates compared to other vaccines in the hemagglutination-inhibition assay .
A gene-based DNA vaccine, used to prime the immune system after boosting with an inactivated H5N1 vaccine, underwent clinical trials in 2011.
On November 20, 2012, Novartis received FDA approval for the first cell-culture vaccine. In 2013, the recombinant influenza vaccine, Flublok, was approved for use in the United States.
On September 17, 2020, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for Supemtek, a quadrivalent influenza vaccine . The applicant for this medicinal product is Sanofi Pasteur. Supemtek was approved for medical use in the European Union in November 2020.
Regulatory Experience And Challenges With New And Novel Influenza Vaccines
As noted earlier, current influenza vaccines are neither rapidly produced, nor ideal in terms of protection. Consequently, significant effort has been expended toward developing and approving improved vaccines, for example, development of quadrivalent vaccines containing antigens from two influenza B virus lineages, cell cultureproduced vaccines, recombinant proteinbased vaccines, and adjuvanted vaccines.
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Flu Shots And Pneumonia
The risk of post-influenza pneumonia is significantly increased according to the number of concurrent comorbidities in older people. In meta-analyses, influenza vaccination significantly reduces pneumonia- and influenza-related hospitalizations. On , the U.S. CDC reported that NCHS mortality surveillance data indicated that 9.8% of the deaths that occurred during week #29 were due to pneumonia, influenza, and/or COVID-19 . Among the 2,050 PIC deaths reported for this week, 1,094 had COVID-19 listed as an underlying or contributing cause of death on the death certificate, and eight listed influenza, indicating that current PIC mortality is due primarily to COVID-19 and pneumonia, but not influenza.
And on May 31, 2022, a peer-reviewed Original Investigation published by The JAMA Network found that ‘Patients with pneumonia admitted to hospitals with high all-cause readmission rates were more likely to develop adverse events during the index hospitalization. This finding strengthens the evidence that readmission rates reflect the quality of hospital care for pneumonia.’
The Flu Vaccine Is Safe
To ensure that the flu vaccine is safe, effective, and of high quality, the FDA prepares and provides reagents to manufacturers that they need to make their vaccine and to verify its identity and potency. The FDA also inspects manufacturing facilities regularly and evaluates each manufacturers vaccine annually before it can be approved.
The FDAs oversight doesnt end there. After manufacturers have distributed their vaccines for use by the public, the FDA and CDC work together to routinely evaluate reports of adverse events following vaccination submitted by vaccine manufacturers, health care providers and vaccine recipients to the Vaccine Adverse Event Reporting System .
Additional efforts are in place to monitor vaccine safety. The FDA partners with private organizations that collect health care data and other federal agencies to further evaluate the safety and effectiveness of the influenza vaccines and other vaccines that the FDA has approved or authorized for emergency use.
The Biologics Effectiveness and Safety Initiative is one of the programs the FDA utilizes to assess vaccine safety and effectiveness in real-world conditions, reflecting patient care and the real-world use of the influenza vaccine and other vaccines in the U.S. In addition, the CDC maintains the Vaccine Safety Datalink program, which evaluates the vaccines safety similar to the BEST Initiative. VSD receives its data from nine integrated health care organizations in the U.S.
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Fda Committee Recommends 20222023 Influenza Vaccine Strains
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has chosen the influenza vaccine strains for the 20222023 season in the northern hemisphere, which beginnings in the fall of 2022.
On March 3, the committee unanimously voted to endorse the World Health Organization’s recommendations as to which influenza strains to include for coverage by vaccines for the upcoming flu season. Two of the four recommended strains are different from last season.
The committee also heard updates on flu activity this season. So far, data from the US Flu Vaccine Effectiveness network, which consists of seven study sites, have not shown that the vaccine is protective against influenza A. “We can say that it is not highly effective,” said Brendan Flannery, PhD, who leads the US Flu VE network for the Centers for Disease Control and Prevention , in an interview with Medscape Medical News. He was not involved with the advisory committee meeting. Flu activity this season has been low, he explained, so there are fewer cases his team can use to estimate vaccine efficacy. “If there’s some benefit, it’s hard for us to show that now,” he said.