Novavax clinical trial
While Novavax hasnt yet sought approval by the Food and Drug Administration (FDA) for its more conventional Covid-19 vaccine, it has recently applied for licensing its vaccine in Australia, Canada, Indonesia, New Zealand, and the U.K. This hasnt gained much traction in the U.S. media, which is odd, given that Novavaxs vaccine could not only help close the equity gap in vaccinations worldwide, but it may also help convince some who are vaccine hesitant to get vaccinated.
If Novavax does submit a marketing application in the U.S. and the FDA approves, the Novavax vaccine has the potential to boost chances of overcoming doubts on the part of the vaccine hesitant. Its a vaccine without the baggage, if you will, of a new technology which people arent familiar with, and may therefore not feel comfortable receiving.
Earlier this week the virologist Dr. Angela Rasmussen tweeted: Ive talked to some unvaccinated folks here in Canada and the U.S. who stated theyd reconsider their position if a more traditional (not mRNA or viral vectored) vaccine were available.
About 57% of the U.S. adult population is fully vaccinated; leaving 43% either partially vaccinated or unvaccinated. Approximately 65 million Americans have had no vaccinations whatsoever.
In the U.S., stubborn vaccine hesitancy has helped shape the trajectory of the Delta variant wave. Peer nations blasted past the U.S. in vaccinating their populations just prior to and during the Delta waves initial onslaught. Adjusting for population, the daily death rate during the Delta wave was about eight times higher in America than in other wealthy nations.
At present, most of the media attention with respect to Covid-19 is on vaccinating en masse children between the ages of five and 11. President Biden tweeted: We have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5-11. But, one wonders whether this really represents a turning point of significance. Additionally, one can question whether there may be some misplaced emphasis on vaccinating young children rather than redoubling efforts to vaccinate the still unvaccinated adults, that is, continuing to try and reach as many unvaccinated folks as possible.
Perhaps theres a sense that further attempts to persuade the unvaccinated will just encounter entrenched resistance. Multiple factors contribute to vaccine hesitancy. Some are more nefarious than others, like intentional misinformation. Other factors arent deliberate deception. Rather, theyre shaped by fear of the unknown, as a new kind of vaccine, namely mRNA, is being used in the real world for the first time.
Viral vector and mRNA Covid-19 vaccines have thus far been the work horses in Western countries. But, these are not the typical vaccines people are accustomed to from childhood. This particularly applies in the case of mRNA vaccines where the only active ingredient is the messenger ribonucleic acid (mRNA), which trains a persons body to recognize and kill the virus.
The Novavaxs Covid-19 vaccine candidate, named Covovax, could be the first approved in the U.S. to rely on a traditional, tried-and-true inoculation method. Its protein-based Covid-19 vaccine employs whats called recombinant nanoparticle technology, distinguishing it from mRNA and viral vector vaccines.
The purified protein, or protein subunit approach which Novavax used to develop its vaccine has been deployed in other vaccines that have been on the market for several decades. The Hepatitis B vaccine, for example, is a subunit agent.
But, the subunit type of vaccine is not the only traditional vaccine. In fact, when people speak of traditional vaccines with long histories theyre referencing a slew of types, from killed and inactivated, to live attenuated, to protein subunit.
An inactivated vaccine consists of virus particles, bacteria, or other pathogens that have been grown in culture and then killed to destroy disease producing capacity. Live vaccines use a weakened (or attenuated) form of the germ that causes a disease. Unlike live attenuated or an inactivated vaccine, a subunit vaccine contains purified parts of the pathogen that are antigenic, or necessary to elicit a protective immune response.
The polio vaccine is a typical example of an inactivated vaccine, as is the combination diphtheria, tetanus, and pertussis vaccine. The combination measles, mumps, and rubella vaccine is a live attenuated agent. Influenza vaccines can be both inactivated and live attenuated.
In September, Novavax applied to the World Health Organization (WHO) for an emergency use listing of its coronavirus vaccine. The company expects to soon be a major distributor to lower and middle-income countries, given that the vaccine has much less onerous storage requirements than the others on the market. Novavax is partnering with the Serum Institute of India on the WHO application, which could facilitate getting the vaccine to countries supported by COVAX, a coalition of international vaccine organizations that are collaborating to provide equitable global access to vaccines.
But, manufacturing concerns continue to plague the company. In fact, production problems at a Novavax facility in Maryland have led to delays in the COVAX vaccine sharing program.
As Novavax continues to work through these issues, the manufacturing delays may be partly to blame for Novavax not yet submitting an application for approval to the FDA. If ultimately approved, Novavax will need to be able to produce at scale in order to have the vaccine serve a dual role: Reducing vaccine hesitancy at home, while helping the global push for vaccination.
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If Approved, The Novavax Covid-19 Vaccine Could Help Reduce Vaccine Hesitancy In The U.S. - Forbes
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