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GreekReporter.com Science Medicine New Vaccine "Novavax" Proves 90% Effective in Clinical Trials

New Vaccine “Novavax” Proves 90% Effective in Clinical Trials

Vaccine
Volunteer receiving the Novavax inoculation as part of its trials recently. Credit: Twitter/Novavax

A new coronavirus vaccine called Novavax, from a company by the same name, has proven to be 90% effective in trials, according to its maker.

The new vaccine candidate appears on the horizon just as inoculations have slowed in the United States, where more than 44% of citizens are now fully vaccinated, but when other regions of the world variants of concern are posing an ever greater problem.

The latest study undertaken by the Novavax firm, headquartered in Gaithersburg, Maryland, trialed the candidate in the United States as well as Mexico. Earlier studies had been undertaken in Great Britain and in South Africa.

The two-inoculation vaccine proved to be approximately 90% effective overall, and according to the company, the preliminary data so far shows that the shot is safe. The effectiveness figures coming out of the study are parallel to those demonstrated by both the Pfizer/BioNTech and Moderna vaccines in their studies.

Now, the United States has more than enough vaccines to meet the slumping demand, and the need for inoculations is desperate in some regions of the world, including Africa, which is referred to now as a “vaccine desert,” in which barely 1% of the people are fully inoculated.

The Novavax vaccine, unlike the Pfizer/BioNTech shot which hit the market first, is very easy to transport and store, offering increased hope to far-flung nations which will be the target for a great many of the doses manufactured as soon as their emergency use is authorized. It can be stored for some time at normal refrigerator temperatures.

However, the next few months hold only more waiting for the vaccine candidate as the company ramps up over the Summer and plans to put the shot before the US Food and Drug Administration and the European Medicines Agency for emergency approval in September.

Plagued by shortages of raw materials used in the shot, production has been hampered up until now; however, Novavax officials state that it will be able to produce up to 100 million doses per month by that time.

“Many of our first doses will go to… low and medium-income countries, and that was the goal to begin with,” stated Novavax CEO Stanley Erck in an Associated Press report.

Now that many states are over 60% fully inoculated — especially in the Northeast, with Vermont now currently leading the way at 61.9% — the stage is set for those in the developing world who are in desperate need at the moment, with only 1% of those in third-world countries having a first inoculation, according to a recent University of Oxford study.

If and when it is approved for emergency use, the Novavax inoculation will be the fifth coronavirus vaccine to be produced in the fight against Covid-19 in the West after the Pfizer/BioNTech, Moderna, Johnson & Johnson and AstraZeneca shots.

The AstraZeneca shot has had a bumpy ride, however, as multiple cases of thrombosis and death in those receiving the shot have been reported. Countries in Europe which continue to employ the vaccine have restricted its use in certain populations; just yesterday, Greece decided that it would no longer offer the vaccine to those under 60.

The Novavax study used almost 30,000 volunteers who were 18 and over, with two-thirds getting two doses of the vaccine three weeks apart. The rest of the volunteers received a placebo shot. Almost half of the volunteers were African-American, Hispanic, Asian American or Native American, and six percent were living in Mexico.

Of the group, 37% suffered from health problems that would predispose them to being at high risk of the coronavirus.

During the course of the study, 77 people became ill with the coronavirus; but only 14 of those who had received the vaccine did so. The rest of those who came down with the virus had received the placebo shots.

Not one in the study who had received the actual Novavax inoculation suffered moderate to severe symptoms, compared to the 14 who did so in the placebo group. One person who had received just the placebo shot passed away during the course of the study.

Most importantly, the Novavax inoculation proved to be effective against several coronavirus variants that are prevalent around the world at the present time, including the British variant, now dubbed the Alpha variant, which is now dominant in the United States and many places around the world.

The Novavax product also proved highly effective in high-risk populations, including the elderly, those who have multiple health problems and even those who work in frontline healthcare occupations.

“These consistent results prove much confidence in the use of this caving for the global population,” says Dr. Paul Heath, the director of the Vaccine Institute at the University of London and St. George’s Hospital, in an interview with the Associated Press.

The side effects reported during the Novavax trials were for the most part mild, and those already associated with any shot, including soreness at the injection site. There were zero reports of blood clotting or heart problems, according to Novavax CEO Erck.

There is a study ongoing in Britain right now as to which shot — including the experimental Novavax inoculation — might serve best as a booster for those who received the Pfizer and AstraZeneca products in their initial inoculations.

The Novavax product may be used in the future as a “universal booster,” according to Kelechi Chikere, an industry analyst, who stated that this may come about because of its high effectiveness rate as well as its reportedly mild side effects.

Novavax officials stated in their announcement that they will be publishing the results of their trials in a scientific journal, where they will be closely looked at by experts in the field.

All coronavirus vaccines condition the human body to recognize the virus, especially the spoke proteins which pop up from its surface, and allow the body to ready itself to fight off the virus.

Novavax created its vaccine with lab-grown copies of the spike protein — which is a different method than that used by the mRNA vaccines produced by Pfizer and Moderna, which include genetic instructions for the body to produce its own spike protein.

Erck noted that the supply issues involving shipments from abroad that hampered production in the last months are now a thing of the past. “That’s opening up,” he stated, adding that the company now has weeks’ worth of raw materials needed for manufacturing of the vaccine in its factories.

Novavax has already committed to supplying 110 million doses of its vaccine to the United States over the next year. It has also earmarked a total of 1.1 billion doses to the countries of the developing world.

The vaccine alliance group called Gavi, one of the groups behind the global vaccine program COVAX, said that it had signed an agreement to purchase 350 million doses of the Novavax product.

COVAX itself has a critical shortage of vaccines since its largest supplier in India, which has been hit especially hard by the virus of late, suspended exports of them until the end of 2021.

Novavax has developed vaccines over the course of its 30-year history but has not brought any of them to market thus far.

The news coming out of the company was welcomed by Dr. Peter English, a vaccine expert who once worked at the British Medical Association. He stated that due to the many complications involved in producing any vaccine, the appearance of the Novavax product on the horizon is especially meaningful.

“Any minor imperfection in the production plant can shut down the production for days or weeks. The more different manufacturers we have producing vaccine, the more likely it is we will have availability of vaccines.”

English also stated that he believed it was encouraging that Novavax can be adapted to address any potential variants that will mutate in the future, if necessary.

 

 

 

 

 

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