2021-01-31
Johnson and Johnson and Novavax
- Break down the Johnson and Johnson single-shot vaccine at 72 percent and Novavax at 89 percent as huge news for ending the pandemic.
- Explain the EUA process and criticize the FDA for withholding AstraZeneca and Novavax despite overwhelming UK data.
- Predict a 90 to 95 percent drop in deaths by mid-year as five platforms and billions of doses come online, making lockdowns politically untenable.
- Detail the variant strategy of genomic surveillance and 100-day mRNA boosters blended into flu shots, though the developing world stays a reservoir.
- Warn that a CRISPR-engineered pandemic could kill a billion, calling this the last chance for a unified global response and demanding accountability.
24 entries
Opens January 31st 2021 from Colorado explaining the vaccine types: RNA from Pfizer and Moderna, the AstraZeneca adenovirus using a genetically engineered animal virus, and protein subunit vaccines grown in modified insect cells on a nanoparticle.
Reports two press releases: Johnson and Johnson at 72 percent effective in the US, 66 overall, and 85 against severe disease, and Novavax's UK trial at 89.3 percent with some South Africa strain escape.
The two vaccine results are great news because Johnson and Johnson is a single-shot platform avoiding the aggressive reactogenicity of second shots that cause sore arms, fevers, and chills, while Novavax is a two-shot but well-received.
Companies then apply for FDA Emergency Use Authorization, filing large open and transparent data packages reviewed by a public committee, as with Pfizer and Moderna in December, and expects Johnson and Johnson to apply in mid-February revealing a transverse myelitis case that delayed the trial.
Questions why the FDA would withhold Novavax and AstraZeneca on UK data, which makes no sense since AstraZeneca is already given to millions in the UK and India despite efficacy debates over age 65 in Germany and France.
Says Johnson and Johnson has gargantuan manufacturing capacity, refrigerator-temperature storage, and single-shot ease for hundreds of millions of doses by summer, laments the Sanofi and GSK failure that set equivalent capacity back nine months, and notes Novavax is confident it can scale to 1.6 billion doses by end of 2021.
With five safe and effective platforms by June, if just Johnson and Johnson were well distributed there would be no lockdowns since the death rate would be lower than influenza.
Predicts a bottoming of lethality over the next six months, already visible in Israel with over half vaccinated, potentially a 90 to 95 percent reduction in deaths by mid-year.
Breaking the pandemic's back means building community resilience, and mRNA platforms are the best for adapting to variants, with Pfizer and Moderna promising custom boosters within 100 days.
Staying ahead needs genomic surveillance sequencing a subset of cases, but the US ranks 43rd, and mRNA platforms are robust since mutations rarely fully escape efficacy, turning would-be severe cases moderate.
Vaccine modifications need no new phase 3 approval like flu shots, so updated vaccines will roll into flu platforms, as Novavax suggested blending its NanoFlu with its covid vaccine, and lays out the strategy of vaccinating 70 to 75 percent, surveilling, modifying within three months, and boosting.
Warns of the developing-world doughnut hole where too few vaccines let the virus keep mutating, so coronavirus may be here forever like the common cold and flu, but no longer novel and far less impactful.
Predicts the world returns to normal by 2022 with no political appetite for lockdowns once the disease is 100 times less lethal, as manufacturing scales and Pfizer explores a freeze-dried vaccine.
Notes local mRNA manufacturing like Germany's CureVac, and says he cares because he wants travel, businesses, and restaurants to reopen, only politically possible once herd immunity drops the death rate.
Calls vaccines a McGuffin politicians latch onto to declare normalcy, but says the economic damage is tremendous with tens of millions suffering long covid, spawning a whole new subfield of medicine.
Predicts five to ten years of investigations, class actions, and corruption scandals, but says the pandemic advanced medicine and mRNA science by decades, likely bringing dozens of custom cancer vaccines and an HIV vaccine in his lifetime plus tens of thousands of new virology researchers.
Is optimistic as US vaccination hits 1.3 million doses daily, heading to two to three million and general availability by April to June once Johnson and Johnson, Novavax, and AstraZeneca add supply.
Expects a long tail of vaccine hesitancy that erodes as social circles get vaccinated and vocations like teaching require it, so covid becomes endemic, the first pandemic managed without natural herd immunity.
Warns that plagues break empires, as the Antonine plague under Marcus Aurelius set Rome on a path to decay, and stresses this is the least lethal pandemic of the 21st century and a wake-up call.
Warns that in the age of CRISPR an engineered virus with a long asymptomatic incubation and a 30 to 40 percent lethal tail like Ebola or the Andes virus could kill over a billion, making another pandemic in the lifetimes of people alive today more than 50 percent likely.
This pandemic is the last chance for a unified global response, since a Cell paper shows how to pre-build vaccines in four months, but the world failed at contact tracing, PPE, and lockdowns except in Vietnam, New Zealand, and Taiwan.
The human cost of friends who lost family, long-covid sufferers unable to work, and laid-off behind-the-scenes entertainment crews, catastrophic for the bottom 25 percent of wages, framing vaccines as the political McGuffin over natural immunity that Sweden tried and was forced to abandon.
Demands quantifying the lost civil liberties and punishing those accountable at the ballot box and with lawsuits, urging removal of statutes of limitation on covid corruption, and says as he gets richer he will fund causes so this never happens again.
Closes that despite fatigue and real information buried under counterproductive narratives, good people worked around the clock to produce hope, and he will tweet the open EUA inserts once filed, as he did for Moderna and Pfizer.