Biotech Company Novavax says it is approaching its finish line with the US Food and Drug Administration (FDA) for full approval of the Covid-19 vaccine. After a long wait, the company issued a cautiously optimistic statement on Wednesday.
We believe that as of the Prescription Drug User Fee Act (PDUFA) after April 1, a Biological License Application (BLA) is available for approval based on conversations with the US Food and Drug Administration (FDA).
The FDA recently submitted a formal request for “off-the-counter commitments.” Essentially, they are asking for more clinical data to be collected after the vaccine has been approved and used. Novavax said it “looks forward to being promptly involved with the FDA” in order to meet these conditions and move towards final approval.
This is not a green light, but a strong yellow. And this step could make Novavax the latest addition to the growing list of fully licensed covid vaccines, despite the continued erosion of wider public trust in these products.
Long, twisty delay
Novavax's path to FDA approval is full of challenges. Initially, the company was aiming to deploy the Covid-19 vaccine in early 2022. However, manufacturing setbacks, regulatory scrutiny and fluctuating demand contributed to significant delays.
In July 2022, the Biden administration purchased 3.2 million Novavacs vaccines subject to recommendations from the FDA's Emergency Use Authorization (EUA) and the Centers for Disease Control and Prevention (CDC). The vaccine received the EUA two days later. By then, a majority of the US population had already been vaccinated with other available vaccines. This has reduced immediate demand for Novavax products.
Following the EUA, Novavax experienced a period of relative inactivity in the US market. Competitors such as Pfizer and Moderna introduced bivalent boosters and updated formulations, but Novavax's presence remained limited. Until August 30, 2024, the FDA revised the EUA to include the updated 2024-2025 formula for Novavax for Americans over the age of 12. The newer version targets the Omicron variant JN.1 strain. In particular, the formula is already outdated, as this strain has been replaced by other variants for a long time.
Anyway, the BLA is currently undergoing final review. With new clinical obligations in place, Novavax hopes that a long-standing bid for full approval will ultimately be successful.
Same risk, different packages
Unlike the mRNA-based shots of Pfizer and Moderna currently on the market, Novavax uses a more “traditional” platform. But that doesn't mean it's risk-free – or fundamentally safe.
The Novavax vaccine is produced using genetically modified insect cells. Specifically, scientists inject MOTH cells with baculoviruses engineered to express the SARS-COV-2 spike protein. These cells produce spike proteins. This is the exact same part of the virus that causes an immune response, and perhaps many negative effects.
In other words, despite the different production methods, the resulting product still introduces spike proteins into the body. It also contains Matrix-M, a new adjuvant derived from saponins found in tree bark.
Speaking to New American in July 2021, Dr. Richard Fleming warned against Novavax's use, claiming that spike proteins are real biological weapons.
The FDA itself lists risks such as myocarditis, pericarditis, inflammation of the injectable site, fatigue, and allergic reactions.
A crowded vaccine scene
If Novavax wins full approval, it will join the packed and increasingly controversial roster of Covid vaccines in the US market.
Thanks to lucrative government contracts and consistent CDC approval, Pfizer Biontec and Moderna continue to control. Both rely on mRNA technology. This provides genetic instructions that encourage the body to produce the spike protein itself. These were the first COVID vaccines approved for full use and remained at the heart of the US vaccination campaign.
Once touted as a simple one-dose option, the Johnson & Johnson vaccine was officially drawn from the US market in 2023.
Now, Novavax is pitching itself as a traditionalist option. This is a protein subunit vaccine intended to appeal to mRNA skeptics. In early April, the company claimed that the shot had fewer short-term side effects than Pfizer. But as outlined above, reality is much more complicated.
It is associated with a wide range of severe side effects, as explained in numerous articles, interviews, and special issue of New American (covid vaccines including Novavax). These include myocarditis and pericarditis. Neurological, immunological and reproductive damage. And even death, especially among young people.
However, to this day, public health officials have been slow to acknowledge and transparently investigate these risks. Moreover, even under the new leadership of Robert F. Kennedy Jr., a once-hard critic of the policy, the Department of Health and Human Services (HHS) continues to support its use among young Americans of six months.
Still protected from liability
Despite the official termination of the 2023 Covid-19 public health emergency, legal protections that protect vaccine manufacturers from liability remain intact.
Under the Public Preparation and Emergency Preparation (PREP) Act, companies that produce Covid-19 vaccines are spared from lawsuits related to injuries or deaths caused by the product. That immunity can only be challenged if “willful misconduct” is proven.
This means that if Novavax is fully approved by the FDA, the harmed recipients will not yet have legal reliance on the manufacturer.
Kennedy has the authority to amend or revoke these legal protections. However, so far, no such movement has been made. Ultimately, the government may once again be asking Americans to trust products whose manufacturers remain fully insulated from the outcome of their failures.
Along with the likelihood of keeping older covid vaccines in the market and adding Novavax to the list, HHS is also working on the Biden era “Project NextGen.” The initiative, backed by billions of fundraising, aims to develop a new generation of covid vaccines and therapeutics.
Overall, despite public fatigue and changing leadership, the federal vaccine agenda is not simply prolonged. It moves the full steam first.
