Yesterday the FDA Advisory committee recommended that the 15 million Americans who have had J&J vaccines, more than 2 months out, get a 2nd shot.
There are some significant issues with this that could have been prevented /1
By May 1, there were over 8 million people 5.5 months out
By June 1, the number rose to nearly 11 million people 4.5 months out
Yet data have consistently been showing attrition of protection vs infections for this vaccine, this week in 620,000 US Veterans /2
This is the only Covid vaccine that was positioned as "one and done." J&J is the largest healthcare company in the world, yet research to back that up was undone until recently.
Single dose: 70% protection vs symptomatic infection
2-dose: 94% protection /3 fda.gov/media/153129/d…
To start with, the 1-shot 70% efficacy vs. symptomatic infections was considerably lower than the mRNA vaccines (95%), the primary endpoint of all Covid vaccine trials, and a proxy for protection vs hospitalizations and deaths
2-shots brought it to parity in the US at 94% /4
A grand total of 17 people were studied for impact on spike protein binding antibody levels (not even neutralization Abs) at 6 months /5
Parenthetically, the antibody level increase from the 2nd J&J shot at 2 months were small relative to a booster with an mRNA vaccine (50-70 fold, 1 month)/6
How could this happen? 15 million Americans potentially left vulnerable and still no formal approval for a 2nd shot 1. J&J did insufficient and late in coming research to backup their "one and done" assertion 2. The poor US tracking of data obscured detection of this issue
/7
We've known about the lapses in antibody levels and reduced protection vs hospitalization for some time, but left these people (who typically had no choice and were told all vaccines were equivalent) susceptible over a prolonged period
Why does the UK currently have 6-fold hospital admissions and a 3-fold higher death rate compared with Europe? ft.com/content/345825…@FT@mroliverbarnes@jburnmurdoch@danieldombey
Among possible explanations, two that stand out are less use of mitigation measures /1
And less vaccination of kids, age 12-17
More reliance on Astra Zeneca vaccines offered as another possible contributing factor
The benefit of the Pfizer boosters across all age groups (vs infections in 16+, vs severe disease 40+), presented @US_FDA today as background for consideration of other vaccine boosters fda.gov/media/153086/d…
In July, many maintained there was no attrition of vaccine effectiveness (VE) vs symptomatic infections or severe disease. Denial of Israeli data.
That continued for months.
In October, all vaccines are getting approvals for boosters to prevent VE attrition in people at high risk
Beyond the mRNAs (Pfizer and Moderna), Astra Zeneca, and J&J, the Chinese vaccines, Sinopharm and Coronavac, are also following suit nature.com/articles/d4158…@Nature
A big mix and match vaccine report in 458 participants with Pfizer, Moderna, J&J, then getting another vaccine 12 weeks later: markedly increased neutralizing antibody response by mixing (up to 76-fold) w/ these 9 combinations (Figure) medrxiv.org/content/10.110… (not Delta strain)
The big takeaway from this dataset is the response to J&J vaccine with a Moderna or Pfizer booster, taking that vaccine with low levels of neutralizing antibodies to close to parity with the mRNAs
(also worked in reverse, J&J boost to mRNA, middle panel)
A few add’l points: 1. 100 μg dose of Moderna booster used here is not (2X) 50 μg proposed by their EUA for FDA tomorrow 2. In prior reports, Astra Zeneca 1st, then mRNA had superior levels of nAbs over mRNA 2 doses, not seen here w/ J&J 3. Assessments were w/ D614G, not Delta
What data does @moderna_tx have to support its 50 ug booster dose? @US_FDA briefing documents provide immune response data across age groups but no evidence of restoration of clinical effectiveness fda.gov/media/152953/d…
The same amended criteria given for Pfizer's emergency authorization are what Moderna is requesting. This will be an interesting VRBPAC meeting that essentially leverages effectiveness data from another vaccine (which I support) vs purists who will claim clinicaldata are lacking
New data have shed light on breakthrough infections across all age groups and multiple vaccines 1. The Israel data on restoration of protection vs severe illness with Pfizer booster shots among 4.6 million people medrxiv.org/content/10.110…
2. The New York State data for decline in protection from confirmed infections in all age groups for Pfizer, Moderna and J&J vaccines among 8.8 million people medrxiv.org/content/10.110…
3. Summary of recent reports for decline (from >90%) in vaccine effectiveness vs symptomatic infections for Pfizer, Moderna, and AZ vaccines
Covid vaccines are essential and have had a profoundly positive impact.
There's controversy as to whether boosters will be useful for age <60.
New data highlights significantly less protection vs symptomatic infections and, to a lesser extent, hospitalizations /1
Summary of the recent data for vaccine effectiveness vs symptomatic infections. At 2 months, this was well over 90% for mRNA vaccines, but by 4-6+ months has declined to between 44-70%.
All ages.
Data for Pfizer, Moderna, and AZ /2