VRBPAC Meeting

June 15, 2023

Agenda

Presentation Focus:

• Reverting to monovalent COVID-19 vaccines based on XBB 1.5.
• Allowing Novavax’s Nuvaxovid COVID-19 vaccine access regardless of previous mRNA doses.
• Creating regulations that allow individuals a new primary series to overcome imprinting.
• Facilitating clinical trials of Novavax for the treatment of long COVID.
• Altering recruitment criteria for Novavax clinical trials to bring a pediatric vaccine to market.

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• The WHO and the EU recommend a Monovalent COVID-19 vaccine based on the XBB 1.5 variant.
• If we go higher than that, we run into the BA.1, BA.2, and BA.5 debacle with XBB being a BA.2 subvariant—leaving the public without a targeted vaccine.

Aligning with WHO and EU Recommendations

Statement on the antigen composition of COVID-19 vaccines, WHO https://www.who.int/news/item/18-05-2023-statement-on-the-antigen-composition-of-covid-19-vaccines

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Bivalent COVID-19 Vaccine

The FDA should recommend a Monovalent COVID-19 vaccine

• Bivalent vaccines have been shown to dilute the antigen, weakening the response while also suffering from immune imprinting.

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• The concern is that this will limit vaccine effectiveness and booster uptake.

Deep immunological imprinting due to the ancestral spike in the current bivalent COVID-19 vaccine

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https://www.biorxiv.org/content/10.1101/2023.05.03.539268v1.full

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Americans Restricted from Novavax

• High demand exists, but FDA’s rules punish people for following its guidelines and getting mRNA first.
• No data supports the concept that it is unsafe to switch from mRNA to Novavax.
• Many countries already allow it.
• Gatekeeping access to Novavax is damaging the perception of the state of Public Health in America.

High Demand for Novavax but Access is Restricted

• Allows full access regardless of previous vaccination status.
• This includes a new primary series.
• Across multiple clinical trials, Novavax has been shown to be safe and effective when used as a heterologous booster after mRNA vaccination.

Israel and Novavax

Novavax Nuvaxovid™ COVID-19 Vaccine Now Available in Israel for Individuals Aged 12 and Older https://ir.novavax.com/2022-09-16-Novavax-Nuvaxovid-TM-COVID-19-Vaccine-Now-Available-in-Israel-for-Individuals-Aged-12-and-Older

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New Alarming Data has Come to Light:

COVID-19 can Cause Brain Cells to Fuse.

https://www.science.org/doi/10.1126/sciadv.adg2248

Having established that SARS-CoV-2 creates syncytia in the brain, inhibiting viral replication in nasopharynx is of the utmost importance.

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It is critical to stop virions from reaching the brain.

Unfortunately, mRNA only offers limited protection in this capacity.

Novavax Reduces Nasal Viral Replication at Exposure

SARS-CoV-2 infection and viral fusogens cause neuronal and glial fusion that compromises neuronal activity https://pmc.ncbi.nlm.nih.gov/articles/PMC10451060/

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A large study in South Korea used a balanced cohort to challenge hospitalization protection of both Novavax and mRNA (Pfizer)...

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Though protection was high for both vaccines, Novavax was shown to be twice as protective against hospitalization in a balanced cohort.

Study: Vaccine Effectiveness in South Korean Adults

Comparative Effectiveness of BNT162b2 and NVX-CoV2373 Vaccines in Korean Adults https://www.medrxiv.org/content/10.1101/2023.02.18.23286136v1

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Waning of mRNA Vaccine Effectiveness

• Internal CDC/FDA data presented at ACIP demonstrated that bivalent mRNA only offers protection against hospitalization for 110 to 170 days.
• Protecting against COVID for a limited time is not sufficient for a virus that can fuse brain cells.
• As it stands, the mRNA vaccine alone is not satisfactory to protect the American people.

Unreleased Vaccine Effectiveness Data, CDC (presented at ACIP)

ACIP Meeting, April 2023

https://youtu.be/1r8UMABcHmY?t=5594

Study: mRNA Needs a Cool-Down Period

Waning of mRNA Vaccine Effectiveness

• mRNA only achieves its best reaction if there is a gap between shots.
• The gap is greater than the window of protection.
• These gaps in protection leave Americans vulnerable to hospitalization from COVID infections.

https://www.aacc.org/media/press-release-archive/2021/08-aug/increasing-the-time-gap-between-covid19-vaccine-doses-leads-to-a-stronger-antibody-response

Novavax Protection

• Vaccine can be taken successively to maintain protection with no gaps.
• It provides consistent protection.
• Response continues to increase beyond anything mRNA has achieved.

Data on 4th Novavax Shot Shows Efficacy of Successive Doses

Immunogenicity and safety of a fourth homologous dose of NVX-CoV2373 https://www.sciencedirect.com/science/article/pii/S0264410X23006126

Extended Protection

• In contrast to mRNA, Novavax has demonstrated that protection from hospitalization has no clear endpoint, extending beyond testing windows.
• This provides consistent protection with no gaps.

Immunogenicity and safety of a fourth homologous dose of NVX-CoV2373

Immunogenicity and safety of a fourth homologous dose of NVX-CoV2373 https://www.sciencedirect.com/science/article/pii/S0264410X23006126

In studies, Novavax consistently demonstrates that their protection extends beyond the testing windows. This stands in contrast to mRNA.

Novavax Received Funding For Its COVID-19 Vaccine As Part of Operation Warp Speed

Funded By Americans

• Novavax was a product of Operation Warp Speed and paid for with US American Tax Dollars.
• Yet Americans have extremely limited access to the product they funded development of.

Explaining Operation Warp Speed

https://www.nihb.org/covid-19/wp-content/uploads/2020/08/Fact-sheet-operation-warp-speed.pdf

CDC Recommendations

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• United States is one of only a few countries using draconian restrictions that prevent access to a vaccine paid for by its citizens.
• We need greater access to Novavax, including a new primary series at least 4 months out from your last COVID vaccine.

CDC Recommendations Don’t Even Suggest Offering Novavax Boosters on top of Novavax

https://www.cdc.gov/vaccines/covid-19/downloads/COVID-19-immunization-schedule-ages-6months-older.pdf

Bivalents Increase Immune Imprinting and Reduce Efficacy

Overcoming Immune Imprinting

• Recent testing has demonstrated that a new primary series is required to consistently elicit a protective immune reaction.
• Not taking this step could lead to an insufficient immune response.
• This could damage the public’s perception of vaccine effectiveness and Public Health.

Repeated Omicron infection alleviates SARS-CoV-2 immune imprinting

https://www.biorxiv.org/content/10.1101/2023.05.01.538516v3

Deep immunological imprinting due to the ancestral spike in the current bivalent COVID-19 vaccine https://www.biorxiv.org/content/10.1101/2023.05.03.539268v1

Novavax for Long Covid

• There have been many anecdotal reports of long COVID patients showing signs of recovery after receiving one or more Novavax vaccines.
• We need studies from the NIH and Novavax into the anecdotal reports showing that Long COVID patients begin recovery after receiving this vaccine.

Anecdotal Reports Showing Potential Benefit of Novavax for Long COVID

Novavax for Long Covid

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• These are just a few examples; there are many similar reports.
• Due to time constraints we can’t show them all here.

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Demand For Novavax Remains High in Spite of Restrictions

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Novavax Fights Every Variant Because of Conserved Epitopes

Long-lasting Potential

• Novavax is designed to target conserved epitopes.
• This effect provides a broad spectrum immune response against variants of concern.
• It is likely that it assists the immune system in finding and targeting persistent virus, which is a primary driver of Long COVID.

Changes are Needed to the Novavax Pediatric Vaccine Trial Recruitment Criteria

• The requirements for Novavax to bring a pediatric vaccine to market are unreasonable and outdated.
• Specifically, regulations requiring that pediatric cohorts be infection or vaccine-naive must be updated.
• The population that they will be vaccinating will not fit that model, and will only delay protection for children.��These restrictions are wholly inappropriate for the situation.

Project NextGen

• Funding needs to be allocated from Project NextGen to expedite the production of the Novavax pediatric COVID vaccine.
• Spending caps created during the debt ceiling deal will limit the ability of Congress to make new investments in treatments and vaccines for at least the next two years.
• We cannot wait that long to protect our children.

Project NextGen Funding Saved from the Debt Ceiling Deal

The outcome of the Debt Ceiling Deal is that Project NextGen may provide the only funding for COVID-19 vaccines in the foreseeable future.

https://www.politico.com/newsletters/future-pulse/2023/06/08/project-nextgen-has-no-warp-speed-00100956

Novavax Restrictions are an Unresolved Vaccine Equity Issue

• Limiting access to Novavax is preventing Americans from being protected against COVID-19.
• It is cruel to limit the tools at hand, especially when vials are going wasted and unused because of outdated regulations.
• Demand exists but the current FDA recommendations artificially limit access; this is unique to America.

More Tweets From Individuals Denied Novavax

Novavax Restrictions are an Unresolved Vaccine Equity Issue

• There are many more examples of Americans that want access to Novavax, but are restricted by this committee’s recommendations.

Americans Want Novavax

Issues to address:

• Next year’s COVID-19 vaccine must be a monovalent vaccine targeting XBB.1.5, but no higher.
• Novavax access must be extended to any Americans who would like to get a new primary series. This is a requirement to avoid immune imprinting.
• Allocate NextGen funding and re-assess the trial recruitment criteria so Novavax can expedite a pediatric vaccine to market.
• Remove the regulation stating that Novavax is only used as a secondary vaccine in cases of refusal.
• Limiting access is a vaccine equity issue, and the FDA is not rising to the moment, but we could fix that today.

Please take the necessary steps to protect the American people.

We need leadership; we need you to be those leaders.