If we have to wait till June for COVOVAX, Indian regulators should hang their heads in shame.
They gave COVAXIN an EUA without any efficacy data or Ph3. Novavax has efficacy data from Ph3 in U.K. and Ph2 in SA. Ph3 in USA and Mexico underway. 1/
Indian regulators literally rewrote the rules for COVAXIN citing hypothetical superior efficacy against variants. What a load of BS (BOGUS science). They made up the restricted EUA in clinical trial mode BS. But a vaccine with 85%+ efficacy in Ph3 against B.1.1.7 is too risky! 2/
Is COVISHIELD good? Yes. But there’s a lack of data for >55 years. That’s more an issue with the trial than the vaccine. Is COVAXIN good? I don’t know, no publicly available Ph3 data. COVOVAX has AMAZING immunogenicity & reported AMAZING efficacy (need 2 wait for the preprint) 3/
We desperately need COVOVAX in India. Higher efficacy, an actual possibility of sterilizing immunity, it’s being manufactured in India. We need to do everything possible to deliver this vaccine ASAP! 4/
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Let me just try to preempt all the BS (bad science) we will hear about hypothetical superiority of COVAXIN against variants vs Novavax. A thread 🧵 1/
Novavax is proven efficacious against OG COVID-19 and B.1.1.7 in a Phase 3 clinical trial in U.K. We should soon have the data in a preprint / peer reviewed publication. The confidence in the results will increase as more cases occur. 2/
Novavax has a Phase 2 trial in South Africa with an efficacy endpoint. That trial reported efficacy albeit reduced against B.1.351. The number of participants in the study was small, number of cases were low and therefore confidence in these results in lower than we need. 3/
2/Study period: 14 days in July 20.
Areas selected:Three wards (R-North, M-West and F-North) in Mumbai were chosen based on: (a) City and Suburban areas (b) East, West and North areas and (c) representative of areas with low to high prevalence based on reported cases on 02/06/20
3/Sampling design: Sampling from households in impoverished tenements or buildings, which were separated by at least 3 households/buildings ensured geographically separate and a systematic method for non-overlapping area coverage.
Those of us following #RECOVERYtrial know it’s one of the most important clinical trials for COVID-19, not just for its potential to identify new therapeutic options but also to temper the excitement over unproven therapies. 1/
My thoughts on the RECOVERY trial PRESS release on mortality benefit for COVID-19 with dexamethasone.
RECOVERY trial is a large randomized controlled trial with multiple arms. 11k+ patients and multiple treatments being evaluated. See image for therapeutics under evaluation. 2/
First, what is dexamethasone?
Dexamethasone is a corticosteroid, commonly called a steroid (not the anabolic kind). In addition to many other effects, it can reduce the inflammatory resonse caused by an out of control immune system. 3/
@ShamikaRavi We explored the possible effect of the monsoons on transmission SARS-CoV-2 in #TheCoronavirusBook. Influenza does activity does spike in the monsoon and post monsoon period in tropical countries. 1/
@ShamikaRavi Possible reasons: clustering of people indoors with increased social contact, high RH + precipitation and decreased solar radiation can prolong viron stability, lower vitamin D levels may play a role. 2/
@ShamikaRavi Let’s look at how influenza’s transmission changes with weather. First let’s distinguish between transmission patterns in temperate countries and tropical countries.
3/
@ICMRDELHI conducted a seroprevalence study across India. In this study, they tested people for antibodies against SARS-CoV-2. Those testing positive have already been infected (with or without symptoms). Seroprevalence studies indicate what % of the country has been infected 1/
The study had 2 parts. The first part, which has been completed, looked at the % of the general population that has been infected. The second part is ongoing and is looking at the % of the population in hot zones that has been infected. 2/
According to ICMR (and this is dependent on the accuracy of their test and the study methodology) 0.73% of the general Indian population may have been infected by SARS-CoV-2 at the time of the study. 3/
1/ We need to optimize testing capacities and remove inefficiencies:
Labs are currently purchasing reagent/kits at different rates. smaller quantities = more $$$.
2/ Build a system where govt negotiates a bulk order price with manufacturers/distributors and allows companies to use CSR $ to buy reagent/kits at that price and hand it over govt.
3/ Govt can redistribute to the labs for free and reduce the cost of testing or charge labs the negotiated rate and reclaim the csr money. In either case the cost of testing goes down.