Johnson & Johnson Gets FDA Clearance on COVID Shots

Posted on 02/28/2021

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The Food and Drug Administration (FDA) cleared Johnson & Johnson’s coronavirus vaccine use in the U.S. The FDA granted an emergency-use authorization for the single-dose vaccine for people 18 and older. This is the third shot available for preventing COVID-19. A committee of outside advisers to the FDA voted unanimously that the vaccine’s benefits outweigh any risks. J&J’s doses can be stored in a refrigerator for long periods.

There is concern over a variant of COVID-19.

How is it different from the Moderna and Pfizer vaccines?

messenger RNA Therapeutic
mRNA vaccine is just the mRNA protected by a protective, fatty covering. The therapy uses synthetic mRNA that contains information about the coronavirus’s signature spike protein. First-ever authorized vaccines that use mRNA. Before 2020, no mRNA technology platform (drug or vaccine) had been authorized for use in humans

Viral Vector Vaccine
Adenovirus vectored vaccines use a virus we know is harmless to act as a Trojan horse. The adenovirus releases genes that encode the SARS-CoV-2 spike protein. Rather than delivering DNA or mRNA directly to cells, some vaccines use a harmless virus or bacterium as a vector, or carrier, to introduce genetic material into cells. Several such recombinant vector vaccines are approved to protect animals from infectious diseases, including rabies and distemper.

Whole-Pathogen Vaccines
Traditional vaccines consist of entire pathogens that have been killed or weakened so that they cannot cause disease. Such whole-pathogen vaccines can elicit strong protective immune responses. Many of the vaccines in clinical use today fall into this category.

Moderna released its 10-K. Some interesting notes include, “Our current COVID-19 vaccine (mRNA-1273) may prove ineffective at providing protection against infection by variant strains of the SARS-CoV-2 virus, and we may be unsuccessful in adapting our COVID-19 vaccine to effectively protect against variant strains of the SARS-CoV-2 virus.”

The report adds, “mRNA drugs have only been authorized for emergency use, or other provisional, interim or conditional use, for COVID-19, and there is no guarantee that any other mRNA drug will be granted an EUA or will be granted full approval in the future as a result of efforts by others or us. mRNA drug development has substantial clinical development and regulatory risks due to the novel nature of this new class of medicines.”

Moderna currently have 24 mRNA development programs in its portfolio, with 13 having entered the clinic.

Seasonal Influenza (Flu)

Influenza most substantially impacts young children and older adults, and current vaccines show low effectiveness.
Seasonal influenza viruses are estimated by the WHO to cause 3 to 5 million cases of severe illness and up to 650,000 deaths each year resulting in a severe challenge to public health. Currently licensed seasonal influenza virus vaccines rarely exceed 60% overall effectiveness and are poorly effective during years when the circulating viruses do not match the strains selected for the vaccine antigens. Particularly in older adults, the population most affected by severe influenza outcomes, vaccine effectiveness remains low.

influenza virus infection can lead to severe disease, especially in high risk groups (including older adults and individuals with comorbidities), and even death (290,000-650,000 respiratory deaths worldwide annually).

Influenza viruses follow a seasonal circulation pattern with increased cases during the winter months in the Northern and Southern hemispheres, respectively. Since influenza viruses continuously change through a process termed antigenic drift, the circulating viruses are actively monitored by a worldwide monitoring network coordinated by the WHO.

HIV

HIV is the virus responsible for acquired immunodeficiency syndrome (AIDS), a lifelong, progressive illness with no effective cure. Approximately 38 million people worldwide are currently living with HIV, with 1.2 million in the U.S. Approximately 2 million new infections of HIV are acquired worldwide every year and approximately 690,000 people die annually due to complications from HIV/AIDS. The primary routes of transmission are sexual intercourse and IV drug use, putting young adults at the highest risk of infection. From 2000 to 2015, a total of $562.6 billion globally was spent on care, treatment and prevention of HIV, representing a significant economic burden. There are no approved HIV vaccines and no effective cure.

NiV

NiV is a zoonotic virus transmitted to humans from animals, contaminated food, or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications from NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40-75%. NiV outbreaks cause significant economic burden to impacted regions due to loss of human life and interventions to prevent further spread, such as the slaughter of infected animals. NiV has been identified as the cause of isolated outbreaks in India, Bangladesh, Malaysia, and Singapore since 2000 and is included on the WHO R&D Blueprint list of epidemic threats needing urgent R&D action.