With old-school technology, can Novavax win over COVID vaccine skeptics?

Since their debut just 18 months ago, three COVID-19 vaccines have saved one about 2.2 million American lives have changed the trajectory of a pandemic and inspired all sorts of them conspiracy theories.

Two of these hits promptly have the recipient’s cells to produce a key piece of the coronavirus following the instructions encoded in the messenger RNA, or mRNA for short. The vaccines developed by Pfizer and Moderna have revolutionized our approach to vaccinations and have done so at blazing speed.

This has left many people wanting something a little more old-fashioned.

A COVID-19 vaccine from Novavax could fit that bill. In a world of fresh ideas about training the immune system to detect and defend against an invading virus, the Novavax vaccine does it the old way: by introducing an exact replica of the coronavirus spike protein into the bloodstream to show the immune system what it is. invader seems.

Add an “adjuvant” – an immunostimulating substance made from purified bark of a South American tree – and voila! You have the kind of vaccine Americans have been using for years to protect themselves from familiar plagues like the flu and shingles.

Yes, nanoparticles and synthetic “recombinant proteins” are involved. Legions of particles of exactly uniform spikes are produced not inside chicken eggs but in army caterpillar cells. These are the hallmarks of a 21S. vaccine of the century, one that has been developed and tested under the auspices of Operation Warp Speed.

But Novavax promotes its technology as a “well-known and established platform” for vaccine creation. His product known as NVX-CoV2373 is expected to be adopted by Americans who are still suspicious of the pillars of mRNA or are not inclined to turn to them as a booster.

Those skeptics cover the range, from people who think mRNA vaccines have been developed and tested too quickly to detect potential long-term side effects (a plausible concern) to those who believe they are implanting movement tracking. microchip in the recipients’ bodies (a fear with no supporting evidence). In between, people are concerned about the impact of vaccines fertility (Current evidence shows no reason to be concerned) and those who fear they do alter a recipient’s DNA permanent (not possible, as the vaccine does not enter the nucleus of a cell, where the DNA resides).

Some people “may prefer tried and true technologies” for COVID-19 vaccines, he said Dr Philip Dubovsky, the chief medical officer of Novavax. While declaring himself a fan of mRNA vaccine technology, he added that others “may not like the concept of … turning their body into a small vaccine factory.”

If made available, the Novavax vaccine could cause some of the still unvaccinated millions of Americans to finally roll up their sleeves. “And when everyone is thoroughly vaccinated, that’s when we can quell” the spread of the coronavirus, she said.

Dr. Gregorio Polanda Mayo Clinic vaccinologist who consulted with Novavax and other COVID-19 vaccine manufacturers described the NVX-CoV2373 marketing niche a little more directly.

“This would not be a ‘genetic vaccine’,” Poland said. “And people who are wary of ‘genetic vaccines’ may find it more tempting.”

This is not its only advantage. Novavax vaccine does not appear to induce the rare but potentially serious type of cardiac inflammation associated with mRNA vaccines. Nor does it cause the strong reactions that have prompted some people who got the mRNA vaccines to postpone their booster shots. Additionally, some anti-abortion activists who refuse to take mRNA vaccines because they were developed with them cell lines derived from an aborted fetus would see it as an acceptable alternative.

But first, the U.S. Food and Drug Administration must clear the vaccine for emergency use, and the Centers for Disease Control and Prevention must recommend it.

Why it took so long is a mystery. Novavax vaccine, known commercially as Nuvaxovid or Covavax, is already authorized for emergency use in 28 countries and approved by the World Health Organization.

“This is a great vaccine, but the FDA has been slowly following it through every step,” said Georgetown University. Lawrence Gostin, expert in public health law. The production hiccup has raised first concerns among US regulators. But those have long since been fixed, and Novavax said it’s on its way produce 2 billion doses this year.

Unlike the shots taken by Pfizer-BioNTech and Moderna, the NVX-CoV2373 does not require refrigeration at ultra-cold temperatures. It is formulated in such a way that it does not need to be reconstituted, making it easier for less skilled operators to administer. And it can be economically and reliably produced by pharmaceutical manufacturers around the world.

All of these attributes make it likely that the Novavax vaccine will play an important role in increasing vaccination coverage in low- and middle-income countries around the world.

“Having the FDA clearing it in the US would boost confidence in this vaccine globally,” Gostin said. This, in turn, could help avoid spikes and prevent the emergence of new coronavirus variants, he said.

A forward-looking move by Novavax could make its candidate a little more attractive to US regulators.

The packing of your immunological load is so efficient that it leaves room for protection from more than one disease. The company, which has a long history of manufacturing flu vaccines, announced In late April, human trials began of a combined injection designed to induce immunity against not only COVID-19 but also four different strains of influenza. It’s also possible that a single Novavax shot could target multiple coronavirus variants in one shot, though Dubovsky said it makes sense to use the shots to protect oneself from “two diseases with one shot.”

Novavax has manufactured and distributed 44 million doses of its purely COVID-19 vaccine since December 2021, and it has gone into arms in a wide range of countries. Indonesia, South Korea, Australia and the European Union were among the first large customers, and Japan joined the list last month. Producers in Japan and India have a contract to produce hundreds of millions of doses.

In clinical studies, NVX-CoV2373-related side effects were mild and rare. The most common complaints were injection site pain, headache, and fatigue. And although mRNA vaccines were linked to myocarditis no cases of potentially life-threatening cardiac inflammation were found in male adolescents and young adults in the Novavax studies.

Although its widespread use abroad is building confidence in the vaccine’s safety, its effectiveness in protecting against COVID-19 – and especially against diseases caused by the Omicron variants that now dominate the world – will be under close scrutiny. by US regulators when appointment on 7 June.

One of the two clinical trials The Food and Drug Administration and its Vaccine Advisory Committee will examine 30,000 adults involved in the United States and Mexico and have found that shots are 100% effective in protecting against mild to moderate cases of COVID-19.

But that trial was conducted at a time when the original coronavirus strain was fading and the Alpha variant and others were establishing themselves. Against these variants, the vaccine’s effectiveness decreased slightly, to 92.6%.

in a second clinical study Conducted in US and Mexican teens ages 12 to 17, the Novavax vaccine was 80 percent effective in preventing COVID-19, largely against the more complicated Delta variant. Compared to adults who received the vaccine, the teenagers’ immune responses were two to three times higher than all variants studied, suggesting it may be suitable for young Americans.

Novavax has not submitted a clinical trial reflecting the success of its vaccine against the Omicron variant. Dubovsky said the vaccine’s steady rate of efficacy over a wide range of variants bodes well for its ability to protect not only from the Micron, but from others that may arise.

Gostin said US officials “just bet the farm on the two mRNA vaccines,” but it’s not too late to add more to the mix. The use of the Johnson & Johnson vaccine has stalled since the CDC declared Pfizer and Moderna vaccines. “favorite … in most cases. ” However, AstraZeneca’s COVID-19 vaccine has never been evaluated by the FDA for the US market. 2.6 billion doses have been delivered all over the world.

“I think it’s not wise,” Gostin said.