nature: COVID vaccines and kids- five questions as trials begin
With a number of COVID-19 vaccine trials now focusing on paediatric populations across various age groups, specific factors need to be considered.
The following article explores issues such as the consent process for paediatric involvment, the robust immune responses of children, and monitoring for signs of exacerbated immune responses and multisystem inflammatory syndrome in children.
Whilst severe COVID-19 disease in children is rare, the immunisation of children against COVID-19 disease will play an important role in achieving herd immunity.
To read more, please read the article below:
nature: COVID vaccines and kids: five questions as trials begin
NEJM: Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants
The following article, published in the NEJM, assessed the vaccine efficacy of Comirnaty™ (BNT162b2) in Qatar where the predominant circulating strains of SARS-CoV-2 were the UK and South African variants.
By extracting information from the national COVID-19 databases, vaccine effectiveness against the B.1.1.7 (UK) strain was estimated at 89.5%, and 75.0% against the B.1.351 (South African) strain. Vaccine effectiveness against severe disease caused by infection with either variant strain was 97.4%.
For more information on these results refer to the link below:
NEJM: Effectiveness of the BNT162b2 Covid-19 Vaccine against the B.1.1.7 and B.1.351 Variants
ऑस्ट्रेलिया मॉडर्ना टीकों को सुरक्षित करता है
ऑस्ट्रेलियाई सरकार ने मॉडर्न COVID-19 वैक्सीन की 25 मिलियन खुराक की आपूर्ति सुनिश्चित कर ली है। यह समझौता मौजूदा मॉडर्न वैक्सीन फॉर्मूलेशन (10 मिलियन डोज) के साथ-साथ वैक्सीन के वैरिएंट-विशिष्ट संस्करणों (15 मिलियन डोज) तक पहुंच की अनुमति देगा ताकि दीर्घकालिक प्रतिरक्षा और उभरते SARS-CoV-2 वेरिएंट की आवश्यकता को पूरा किया जा सके।
नैदानिक परीक्षण के परिणामों ने प्रदर्शित किया है कि मॉडर्न वैक्सीन में गंभीर COVID-19 रोग के खिलाफ 100% प्रभावकारिता है, साथ ही दूसरी खुराक के कम से कम 6 महीने बाद 90% की लंबी अवधि की प्रभावकारिता है। ऑस्ट्रेलिया को वैक्सीन की आपूर्ति तभी शुरू होगी जब थेराप्यूटिक गुड्स एडमिनिस्ट्रेशन (टीजीए) द्वारा मंजूरी प्रदान की जाएगी।
वैक्सीन की निरंतर आपूर्ति सुनिश्चित करने के लिए ऑस्ट्रेलिया के भीतर विनिर्माण सुविधाओं की स्थापना के संबंध में मॉडर्ना के साथ भी चर्चा चल रही है।
अधिक पढ़ने के लिए नीचे दिए गए लिंक का अनुसरण करें:
ऑस्ट्रेलिया मॉडर्ना टीकों को सुरक्षित करता है
NEJM: Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant
Novavax have published preliminary phase 2a-b clinical trial results for their COVID-19 vaccine candidate (NVX-CoV2373), assessing vaccine efficacy against SARS-CoV-2 variants (B.1.351- South African strain). This vaccine candidate is a nanoparticle based vaccine containing pieces of the SARS-CoV-2 spike protein.
In this study, participants aged between 18 and 84 years, received either a 2 dose course of the candidate vaccine or a 2 dose course of a placebo (normal saline). Approximately 30% of participants were seropositive for SARS-CoV-2 prior to commencing the trial. Among the seronegative participants, approximately 94% were HIV-negative and 6% were HIV-positive.
A vaccine efficacy of 49.4% was seen among participants who were seronegative at baseline, regardless of HIV status. In the HIV-negative cohort, vaccine efficacy was 60.1%. A history of previous SARS-CoV-2 infection did not reduce the risk of subsequent infection with the new variants of SARS-CoV-2.
To read the article and view these results in full please refer to the below link:
NEJM: Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant
New resource: Australia's COVID-19 vaccine rollout
For easily accessible information relating to the COVID-19 vaccine rollout, the Australian Government Department of Health have created a new resource page. This page will be updated daily and describes the number of vaccine doses administered via the various providers, makes comparisons to international COVID-19 vaccine programs, and provides other sources of useful data.
To view this page please refer to the link below:
Australian Government Department of Health: Australia's COVID-19 vaccine rollout
NEJM: Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
Whilst there is currently limited safety data on the use of COVID-19 vaccines in pregnancy, immunisation in this patient group is not contraindicated. ATAGI advises that COVID-19 immunisation may be recommended after considering factors such exposure risk and underlying medical conditions.
The following study involving 35,691 pregnant participants who received mRNA COVID-19 vaccines did not show any safety signals regarding pregnancy or neonatal outcomes. Preliminary results showed that injection site pain was reported more commonly amongst pregnant women than non-pregnant women, and headache, myalgia, chills and fever were reported less commonly.
अधिक पढ़ने के लिए, नीचे दिए गए लिंक का अनुसरण करें:
NEJM: Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
VACSIG Webinar Events: Register to attend
The Vaccination Special Interest Group (VACSIG) will be hosting a webinar on Wednesday 5 May featuring a panel of expert speakers including MVEC's Professor Jim Buttery and A/Prof Nigel Crawford. The topic for the webinar is COVID-19 vaccines and rare side effects - now blood clots/bleeding, what’s next?. This event is open to both ASID members and non-members. Further information and details on registration can be found via the link below:
VACSIG Webinar Wednesday 5 May
ATAGI reinforce recommendations on use of COVID-19 vaccines following review of vaccine safety data and benefits
As of April 23, 2021 a total of 6 cases of थ्रोम्बोसाइटोपेनिया सिंड्रोम के साथ घनास्त्रता have been reported in Australia in people who have received dose 1 of COVID-19 AstraZeneca. Severity of cases have varied including 1 fatal outcome. In all reported cases, symptoms of TTS began 4-26 days after immunisation.
The latest statement from ATAGI reinforces the current advice:
- Comirnaty™ is the prefered COVID-19 vaccine brand for administration in those < 50 years of age. COVID-19 AstraZeneca may be administered in this age group if the benefits of immunisation are deemed to outweigh any risks
- Due to the ongoing potential for a COVID-19 outbreak, as well as an increased risk of severe disease and mortality associated with COVID-19 infection, the benefit of immunisation with COVID-19 AstraZeneca for adults > 50 years of age continues to outweigh the risks associated with the vaccine
- TTS can occur at any age, however current evidence shows that the incidence of TTS is less for older adults than younger adults
- ATAGI continues to recommend that people who received the first dose of COVID-19 AstraZeneca without any serious adverse event (eg. anaphylaxis or TTS) can receive the second dose. Current data suggests that the risk of TTS following receipt of a second dose of COVID-19 AstraZeneca is considerably lower. From more than 2 million second doses administered internationally, there has been 1 case of TTS reported following dose 2 of COVID-19 AstraZeneca (reported in the UK)
To read the statement in full refer to the link below:
TGA: Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved
The Therapeutic Goods Administration (TGA) have approved wider storage and transportation conditions for Comirnaty™ (the Pfizer COVID-19 vaccine).
Long-term storage of Comirnaty™ still requires ultra-cold temperatures of -90°C to -60°C. Unopened vials can be stored and transported at domestic freezer temperatures (-25°C to -15°C) for up to 2 weeks. Vials stored or transported at domestic freezer temperatures can be returned to ultra-cold longer term storage within the original shelf life of the product. Unopened vials can be stored for up to 5 days at temperatures of 2°C to 8°C. Once thawed, Comirnaty™ cannot be refrozen.
Once diluted, Comirnaty™ can be stored or transported at room temperatures of up to 30°C for up to 6 hours either in vials or syringes.
The product information contains the most up-to-date storage and transport requirements.
The full TGA statement can be accessed via the link below:
TGA: Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved
Reuters: Canada’s Ontario to expand use of AstraZeneca COVID vaccine as epidemic rages
As a third wave of COVID-19 infections spreads across Canada, a change in recommendation for the COVID-19 vaccine rollout has been announced for Ontario. People who will turn 40 years of age this year can now be offered the AstraZeneca COVID-19 vaccine.
Last month, Health Canada (the medicines regulatory board) advised that administration of the AstraZeneca COVID-19 vaccine be limited to those over 55 years of age. This age limit was put in place following reports globally of serious blood clots and bleeding in people who had received COVID-19 AstraZeneca.
With 4,250 new cases of COVID-19 infection diagnosed in Ontario on Sunday and a total of 737 patients requiring intensive care, the benefits of immunising a younger age group is now deemed to outweigh any risk of side effects.
It is recommended that following immunisation, anyone who experiences shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms like severe headaches or blurred vision, or skin bruising or tiny blood spots under the skin beyond the site of the injection seek medical attention.
To read more about the change in recommendation refer to the below link:
Reuters: Canada’s Ontario to expand use of AstraZeneca COVID vaccine as epidemic rages