Pause of AZD1222 vaccine by some EU countries (Germany, Denmark, etc.) when UK has not raised any concerns, is relevant for India because > 85% of vaccine currently being admin in India is COVISHIELD (SII's AZD1222).
👉A comprehensive summary of key points from European Medical Agency's assessment of Thromobocytopenia.
Key confirmation from EMA's safety committee:
1. Benefits of AZD1222 (COVISHIELD) still outweigh the risks despite possible link to rare blood clots with low blood platelets.
2. No evidence of a problem related to specific batches of the vaccine or to particular mfg sites.
3. the vaccine may be associated w/ very rare cases of blood clots associated w/ thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it toclot) w/
or w/o bleeding, including rare cases of clots in vessels draining blood from the brain (CVST).
~20 million people in UK & EEA had got vaccine as of 16 March & EMA had reviewed only 7 cases of blood clots in multiple blood vessels (disseminated intravascular coagulation, DIC) &
18 cases of CVST. A causal link w/ thevaccine is not proven, but is possible and deserves further analysis.
9 of DIC & CVST cases from member states resulted in deaths. Most of these occurred in people < 55 years & majority were women👩.
Difficult to look at background rate.
However, based on pre-COVID figures it was calculated
that < 1 reported case of DIC might have been expected by 16 March among people < 50 w/in 14 days of receiving vaccine, whereas 5 cases had been reported. Similarly, on avg 1.35 cases of CVST might have been expected among
this age group whereas by the same cut-off date there had been 12.
Information for vaccine recipients (left pic) and health professionals (right pic):
🚨 (Amended) Product Information of AstraZeneca/Oxford COVID19 vaccine (COVISHIELD if mfg by SII, India) as approved by CHMP, @EMA_News on 19 March 2021, pending endorsement by @EU_Commission: ema.europa.eu/en/documents/p…
Product Info of COVISHIELD in India also needs to be updated.
Seek immediate medical attention if AEFI like
- shortness of breath, chest pain, leg swelling, or
persistent abdominal pain
- severe or persistent headaches or blurred vision, or experience skin bruising or pinpoint round spots beyond site of jab which appears after a few days
Based on clinical/laboratory features of 9 patients in Germany & Austria, a study finds: AZD1222 is associated w/ development of prothrombotic disorder that clinically resembles heparin-induced thrombocytopenia but which shows different serological profile researchsquare.com/article/rs-362…
At least 4 cases in India of thrombocytopenia post COVISHIELD, includes-
33yr/F (vaccine: 22 Jan, death: 3 Feb) w/ death cause earlier reported as "cerebral thrombosis" after post-mortem
80yr/M: AEFI- low platelets initially, later intracranial bleeding
Bijwerkingencentrum Lareb, Netherlands has received 5 reports of extensive thrombosis w/ a low platelet count following vaccination with Vaxzevria (COVISHIELD). It occurred 7 to 10 days after vaccination. These are women between 25 & 65 years old. lareb.nl/news/meldingen…
Vaxzevria (COVISHIELD): As of 4 April 2021, 169 cases of CVST & 53 cases of splanchnic vein thrombosis reported to EudraVigilance.
🚨EMA has concluded that unusual blood clots w/ low blood platelets should be listed as very rare side effects of Vaxzevria. ema.europa.eu/en/news/astraz…
A short commentary on @MHRAgovuk assessment of reported very rare AEFI: specific blood clots (thrombosis) with low platelets count (thrombocytopenia) associated w/ Vaxzevria (COVISHIELD).
1. Benefits of vaccine outweighs risk for vast majority of people. By 31 March, 20 million
doses have been give. MHRA had 79 case reports upto & including 31st March, 19 people died. All cases post 1st dose. Cases occurred in 51 women and 28 men, all in age group 18 to 79 years.
2. Risk of this rare blood clot about 4 people in a million. Among deceased, 3 out of 19
under 30 years. 4 out of 19 were of cerebral venous sinus thrombosis w/ low platelets, and 5 were other kinds of thrombosis in major veins.
3. Balance of benefits to risk is very favorable in older people & more finely balanced in younger people. Advise on how to minimize risk.
4. Anyone w/ symptoms 4 or more days post vaccination should seek prompt medical advice, new onset of a severe or persistent headache or blurred vision, shortness of breathe, chest pain, leg swelling, persistent abdominal pain, or indeed unusual skin bruising or pinpoint spots.
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How are major arguments used by @kiranshaw here not different than arguments made by @yogrishiramdev on #CORONIL? Both playing on emotions like "made in India", "used since ages", "rigorous clinical trials not so relevant in pandemic". @CDSCO_INDIA_INF
🚩What is community transmission? Is India under community transmission?
⚠️What are implications of community transmission? Why is @MoHFW_INDIA denying it?
🧐What are possible consequences if there's declaration of community transmission? How will it help public? (thread)\1
@WHO's definition of community transmission allows govts to announce/deny community transmission based on their agenda. Maybe vague but @MoHFW_INDIA is NOT in position to defend its denial. "COMMUNITY TRANSMISSION" is officially used in @MoHFW_INDIA's critical policy/rules. \2
March 23 by 1800 IST, 2020, we officially had 433 COVID-19 cases, 7 deaths, 402 active. @PMOIndia declares nationwide strict lockdown for ~2 months. Only few places officially had local transmission on. Today, 25 states/UTs have 500+ active cases each. \3
IMO, we are often not asking questions appropriate to priority.
e.g.,
1. Ask about quality, quantity, delivery status of medical devices (PPE, N95 masks, ventilators, sanitizers, etc.). NOT price even if its via #PMCARES. \1
Lives are getting lost due to delay, low quality, shortage while disease keeps spreading. You need to save healthcare workers else who will take care of patients even if we keep adding beds.
Money NOT an issue, have $2250 million loan from World Bank+ AIIB alone for COVID18.\2
Need obsession w/ saving lives & economy of country. We can ask about #PMCARES even later, but can lives lost due to shortage/quality/delay be brought back? No. Your question should determine your priority goal.
❗️COMMUNITY TRANSMISSION on.
❗️UTTERLY LIMITED test capacity & medical facility.
❗️NO ESTIMATE FOR % ASYMPTOMATIC, not in India and not for global popn!
❗️still EARLY stage. \1
❗️PRE-SYMPTOMATIC ≠ ASYMPTOMATIC.
❗️Pre-symptomatic can be EXTREMELY contagious as symptomatic ones.
❗️ECOLOGICAL FALLACY is BLUNDER.
❗️Self-ISOLATION/QUARANTINE when suspicious of exposure to infection is MUST.
❗️AVERAGE w/o RANGE, CONFIDENCE INTERVAL (where relevant), and SAMPLE SIZE holds too little or NO meaning.
❗️There're LIMITS to STATISTICAL INFERENCE, which SHOULDN'T be ignored.
❗️FORGED data yields USELESS calculation w/ NO valuable inferences even if plots look PRETTY. \3
❗️What're some of India's elite COVID19 calculators (@NITIAayog, @ICMRDELHI, majority of media) getting wrong? Here are some monumental blunders in elementary analysis of numbers related to COVID19 cases in India.
Rule 1: If facts are misrepresented, analysis will be wrong! /1
1. An ecological fallacy: 1st, we keep/kept deducing about the spread of infection in India by inferring global data (avg.).
Same at level of India, focused on average rather than local level data barring few states/districts. Need extensive analysis of data at local level. \2
Examples: We haven't done surveillance test or case study in India to estimate % of asymptomatic case, avg period of incubation, estimate for how much % of popn show symptoms in which week, avg recovery period from day of symptoms onset, etc. We apply arbitrary estimation .... \3