A thread on recent updates (24 March- 9 April 2021) on Vaxzevria, a COVID19 vaccine mfg by AstraZeneca (called COVISHIELD if the same product is mfg by @SerumInstIndia).
1. Summary of productcharacteristics updated by @AstraZeneca after @EU_Commission's decision. Importantly,
a) Thromobocytopenia is listed as common (≥1/100 to <1/10) adverse reaction
b) Thrombosis in combination w/ thrombocytopenia is listed as very rare (<1/10,000) adverse reaction
c) Currently available trial data do not allow an estimate of vaccine efficacy in 55+ yrs age group.
d) Asks healthcare professionals to be on alert for signs & symptoms of thromboembolism &/or thrombocytopenia. Instructs vaccinated people to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, persistent abdominal pain
following vaccination. Additionally, anyone w/ neurological symptoms including severe or persistent headaches or blurred vision after vaccination, or who experiences skin bruising (petechia) beyond the site of vaccination after a few days, should seek prompt medical attention.
2. Package leaflet updated by @AstraZeneca. Some important mentions are:
a) Mentions that 2-dose vaccination course of Vaxzevria may not fully protect all those who
receive it. Not known how long protection lasts. Currently there are limited data on efficacy of Vaxzevria in 55+
yrs age group.
b) In possible side-effects,
i) asks to get URGENT medical attention if recipient gets symptoms of a severe allergic reaction. Such reactions may include a combination of any of following symptoms: feeling faint or light-headed, changes in heartbeat, shortness of
breath, wheezing, swelling of lips, face, or throat, hives or rash, nausea or vomiting, stomach pain.
ii) Low level of blood platelets listed as common AEFI (may affect up to 1 in 10 people)
iii) Blood clots often in unusual locations (e.g. brain, bowel, liver, spleen) in
combination w/ low level of blood platelets listed as very rare AEFI (may affect up to 1 in 10000 people).
3. @AstraZeneca in agreement w/ EMA & <National Competent Authority> released alert for health professionals on risk of thrombocytopenia & coagulation disorders, 24/03/2021
4. PRAC, EMA has started the review of a safety signal to assess AEFI reports of Capillary Leak Syndrome (CLS) (after 5 CLS cases were reported).
In some cases w/ similar clinical/radiological pictures as TTS, anti-PF4 antibodies remained -ve & in some of those cases no thrombocytopenia or coagulation disorders were observed.
🚨Product info of Vaxzevria (COVISHIELD), approved by CHMP on 20 May 2021. Some revisions on possible AEFIs:
Addition of Immune system disorders (unknown frequency)– Anaphylaxis & Hypersensitivity.
Mentions that transient mild thrombocytopenia was commonly reported in trials.
Contraindications to not give booster dose of COVISHIELD to those who previously had TTS after COVISHIELD.
Those w/ thrombocytopenia w/in 3 week after COVISHIELD be alert of thrombosis, & vice-versa.
Hypersensitivity reactions presenting as hives or rapid swelling under skin in
in areas such as face, lips, mouth & throat are newly identified side effects. [Hypersensitivity reaction of urticaria as new uncommon side effect, & angioedema]
AEFIs cases of Capillary leak syndrome, Guillain-Barré syndrome, & Acute macular neuroretinopathy are under review.
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A short note on dosing regimen of COVISHIELD for complete vaccination.
We've 3 different set of trials:
1. UK/Brazil trials
This trial was open-label, w/ scandalous error in dosing regimen ("half-dose" error), had multiple major amendments in protocol when trial was undergoing
w/ minimum gap b/w 2 doses set to be 4 weeks.
COVISHIELD was initially supposed to be a single dose vaccine, but in middle of trial they realized that booster dose was required for higher efficacy compared to just single dose.
In the process, due to mfg/supply delay, intended
interval of 4 weeks was not achieved & got prolonged.
Attached are intended & extrapolated sub-group analysis that was carried out by PIs as part of protocol, w/ different dosing levels & intervals.
*extrapolated analyses were not part of protocol hypothesis but in response to
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).
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.