Can Novavax beat COVID vaccine skeptics with old-fashioned technology?

Three COVID-19 vaccines have been released since their debut just 18 months ago Estimated 2.2 million American life has changed the course of the pandemic and inspired all sorts of things. Conspiracy theory..

Two of these shots prompt the recipient’s own cells to produce an important part of the coronavirus by following instructions encoded in messenger RNA (mRNA for short). The vaccine developed by Pfizer and Moderna has revolutionized the approach to immunization, achieving it at a dazzling rate.

That’s why many people yearn for older schools.

COVID-19 vaccine from Novavax It may fit the bill. In a world of new ideas about training the immune system to find and defend against invading viruses, the Novavax vaccine does it the old-fashioned way: introducing an exact replica of the coronavirus spike protein into the bloodstream. The intruder looks like what it shows to the immune system.

Add an “immude” — an immunopotentiator made from purified bark South American trees — And voilà! You have the type of vaccine that Americans have been taking for years to protect themselves from familiar tragedy such as the flu and shingles.

Yes, nanoparticles and synthetic “recombinant proteins” are involved. An army of precisely uniform spike particles is produced within the cells of the Army caterpillars, not inside chicken eggs.These are 21 features^st Vaccines of the century, developed and tested With the support of Operation Warp Speed..

However, Novavax touts the technology as a “famous and established platform” for building vaccines. It hopes that its product, known as NVX-CoV2373, will be accepted by Americans who are still skeptical of mRNA’s flagship or are reluctant to rely on them as boosters.

These skeptics cover everything from those who believe that mRNA vaccine development and testing is too fast to detect potential long-term side effects (plausible concerns) to those who believe that exercise tracking will be transplanted. I am. Microchip On the recipient’s body (fear without supporting evidence).In the meantime, some people are worried about the effects of the vaccine. Fertility (Current evidence does not give a reason to worry) and those who are afraid of them Modify the recipient’s DNA Permanently (vaccines are not possible because they do not enter the nucleus of the cell in which the DNA resides).

Some people have stated that the COVID-19 vaccine “may prefer a proven and true technique.” Dr. Philip Dubovsky, 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.”

When the Novavax vaccine becomes available, millions of unvaccinated Americans could finally roll up their sleeves. “And when everyone is thoroughly vaccinated, it’s time for us to weaken,” he said.

Dr. Gregory PolandThe May York Clinic vaccine scholar, who consulted with Novavax and other COVID-19 vaccine makers, explained the marketing niche of NVX-CoV2373 a little more directly.

“This would not be a’gene vaccine’,” Poland said. “And those who are wary of’gene vaccines’ may find it more attractive. “

That’s not the only good thing. The Novavax vaccine does not appear to induce a rare but potentially serious type of heart inflammation associated with the mRNA vaccine. It also does not provoke a strong reaction that some people vaccinated with the mRNA vaccinated have urged to postpone booster shots.In addition, the mRNA vaccine Cell line derived from a miscarriage fetus We would consider it an acceptable alternative.

But first, the US Food and Drug Administration needs to authorize a vaccine for emergency use, and the Centers for Disease Control and Prevention must recommend it.

It is a mystery why it took so long. The Novavax vaccine, commercially known as Nuvaxovid or Covavax, has already been approved for emergency use in 28 countries. Approved by the World Health Organization..

“This is a very good vaccine, but the FDA is slowly walking at every stage,” said Georgetown University. Lawrence Gostin, A public health law expert. The temporary suspension of manufacturing has raised early concerns among US regulatory agencies.But they have been resolved for a long time and Novavax says it’s going well. Generate 2 billion doses This year.

Unlike shots by Pfizer-BioNTech and Moderna, NVX-CoV2373 does not require refrigeration at ultra-low temperatures. Formulated so that it does not need to be reconfigured, it is easy to manage with less skilled handlers. And it can be produced cheaply and reliably by pharmaceutical companies around the world.

With all these attributes, the Novavax vaccine has the potential to play an important role in expanding vaccine coverage in low- and middle-income countries around the world.

“The FDA’s approval of it in the United States will increase confidence in the vaccine globally,” Gostin said. It, in turn, could help avoid the surge and prevent the emergence of new coronavirus variants, he said.

One of the positive moves by Novavax could make the candidate a little more attractive to US regulatory agencies.

The packaging of its immunological payload is so efficient that there is room for protection from multiple illnesses. The company, which has a long history of producing influenza vaccines, publication In late April, human trials of combination shots designed to induce immunity against four different strains of influenza, as well as COVID-19, began. Dubovsky said it makes sense to use shots to protect “from two illnesses in one jab”, but one Novavax shot has multiple coronaviruses in one shot. It may even target variants.

Since December 2021, Novavax has manufactured and distributed 44 million doses of pure COVID-19 vaccine and is used in various countries. Indonesia, South Korea, Australia and the European Union were the first major customers, and Japan was added to the list last month. Manufacturers in Japan and India have contracts to produce hundreds of millions of doses.

In clinical trials, side effects associated with NVX-CoV2373 are mild and rare. The most common complaints were pain at the injection site, headache, and malaise.And the mRNA vaccine Related to myocarditis In male adolescents and young adults, potentially dangerous cases of heart inflammation have not been detected in the Novavax trial.

Its widespread use abroad has increased confidence in the safety of vaccines, but its effectiveness in protecting against COVID-19, especially from diseases caused by the Omicron variants that currently dominate the world. Gender is subject to close scrutiny by US regulatory agencies. Meet on June 7th..

One of two clinical trials The Food and Drug Administration and its Vaccine Advisory Board surveyed 30,000 adults in the United States and Mexico and found that they were 100% effective in protecting against mild and moderate cases of COVID-19.

However, the test was conducted when the original coronavirus strain was declining and alpha mutants and the like were being established. Vaccine efficacy was slightly reduced for these mutants to 92.6%.

so Second clinical trial The Novavax vaccine, performed in US and Mexican adolescents aged 12 to 17 years, showed 80% overall efficacy in preventing COVID-19, primarily against tricky delta variants. When compared to vaccinated adults, the immune response of teens is about 2-3 times higher against all the mutants studied and may be suitable for young Americans.

Novavax has not submitted any clinical trials that reflect the success of the vaccine against the Omicron variant. Dubovsky argued that the stable efficacy of the vaccine across a wide range of variants is sufficient to protect it not only from Omicron, but also from other vaccines that may develop.

“We’ve just bet the farm on two mRNA vaccines,” Gostin said, but it’s not too late to add the other vaccines to the mix. The use of Johnson & Johnson vaccines has stagnated since the CDC declared the Pfizer and Moderna vaccines.Priority … in most situations.. AstraZeneca’s COVID-19 vaccine has never been evaluated by the FDA for the US market. 2.6 billion doses It is distributed all over the world.

“I don’t think it’s wise,” Gostin said.