BBC- Covid: New Oxford vaccine 'ready by the autumn' to tackle mutations
With the emergence of various mutations of SARS-CoV-2 there is still reassuring evidence that existing vaccines are providing good protection, although at a slightly less rate than with the initial variants. Additionally, interim results released by the Oxford/AstraZeneca team showed that vaccination with the Oxford/AstraZeneca COVID-19 vaccine could cut transmission of the virus by up to 67%.
In the following article published in the BBC, Professor Andy Pollard from Oxford University suggests that updating vaccines to make them more effective against mutations is a quick process. With manufacturing processes already established, newer vaccines could be available relatively quickly.
To read more follow the link below:
BBC- Covid: New Oxford vaccine 'ready by the autumn' to tackle mutations
Latest monitoring data confirms safety of COVID-19 vaccines
Data from the UK's independent medicines regulator (MHRA) has confirmed that the safety profile of the approved COVID-19 vaccines (Oxford Astra/Zeneca and Pfizer/BioNTech) remains as high as reported in the clinical trial data that supported those approvals.
With over 10 million doses already delivered, there have been 22,820 reports of suspected side effects with the majority being short-lasting, mild and expected side effects including sore arms and 'flu-like' symptoms.
To read the press release in full follow the link below:
Latest monitoring data confirms safety of COVID-19 vaccines
JAMA Pediatrics: Assessment of Maternal and Neonatal Cord Blood SARS-CoV-2 Antibodies and Placental Transfer Ratio
A recent cohort study conducted at Pennsylvania Hospital, Philadelphia involving 1714 participants assessed maternal and cord blood for the transfer of SARS-CoV-2 antibodies. Trial participants were from various ethnic backgrounds with ages ranging from 28-35 years. IgG and/or IgM was detected in 83 woman at the time of delivery and IgG was detected in the cord blood of 72 of the 83 infants. The transfer of antibodies occurred after symptomatic and asymptomatic infections during pregnancy.
To read the article in full refer to the link below:
Community pharmacies to participate in COVID-19 vaccination program
The Australian Government has announced an expression of interest (EOI) process has begun for community pharmacies to participate in the COVID-19 vaccination program.
Participation is voluntary, with pharmacies needing to demonstrate their capacity, capability and ability to meet high safety standards.
Eligible pharmacies would be able to deliver COVID-19 vaccines to priority populations from phase 2a of the of Australian COVID-19 vaccination rollout strategy (expected to be in May 2021). They would be incentivised to provide both doses of the AstraZeneca COVID-19 vaccine in an effort to increase uptake of the vaccine.
Read more about this in the Health Minister’s statement via the link below:
Community Pharmacy to join COVID-19 vaccine workforce
Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial
Novavax have released interim results for both its UK phase III clinical trial as well as for the phase 2b studies being conducted in South Africa.
The UK phase III clinical trial involves more than 15,000 participants aged 18-84 years. During a period of high transmission with the UK variant of SARS-CoV-2, the preliminary results show an efficacy rate of 89.3%. After review of the vaccine safety database it has also been reported that any adverse events were balanced between both the vaccine and the placebo groups and any serious or severe side effects occurred at low levels.
In the South African phase 2b clinical trial, an efficacy rate of 60% was seen in the HIV-negative cohort, with an overall 49.4% efficacy rate seen across the total 4,400 trial participants (both HIV-negative and HIV positive individuals). During the time of the trial, the South African variant of SARS-CoV-2 was widely circulating.
The Novavax COVID-19 vaccine candidate is a protein-based vaccine utilising a nanoparticle technology platform.
To read the full press release follow the link below:
Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial
TGA provisionally approves Pfizer COVID-19 vaccine
Following a thorough and independent review, the Therapeutic Goods Administration (TGA) has found that the Pfizer/BioNTech COVID-19 vaccine candidate, Comirnaty, meets the strict safety and efficacy standards required for provisional approval. It is now provisionally approved for use in those aged 16 years or older for active immunisation to prevent COVID-19 disease.
For more information please refer to the links below:
TGA provisionally approves Pfizer COVID-19 vaccine
COVID-19 vaccine: Pfizer Australia - COMIRNATY BNT162b2 (mRNA)
For more information on the provisional pathway of vaccine approval, please refer to our reference page below:
MVEC: Provisional registration of COVID-19 vaccine(s) in Australia
TGA grants additional provisional determination for a COVID-19 vaccine
The Therapeutic Goods Administration (TGA) has granted provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) for their COVID-19 vaccine candidate.
Granting provisional determination means that Biocelect (on behalf of Novavax) is now eligible to apply for provisional registration. Following the provisional pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.
Provisional determination is only granted once the TGA has considered all eligibility criteria, including evidence of a plan to submit comprehensive clinical data.
You can read the press release from the TGA below:
TGA grants additional provisional determination for a COVID-19 vaccine
For more information on the process of COVID-19 vaccine provisional approval please refer to our reference page:
MVEC: Provisional registration of COVID-19 vaccine(s) in Australia
The Times of Israel: Israel expands vaccination campaign to teens aged 16-18
Israel have expanded their COVID-19 vaccination program to include teenagers aged ≥ 16 years, with the first vaccines being given in this age group on January 23.
Initial immunisation in Israel began in December 2020, prioritising health care workers, the elderly and other at-risk groups. To date, 2.5 million people have received a dose of the Pfizer BioNTech COVID-19 vaccine, with 900 thousand of those, also having received their second dose.
To read more, follow the link below:
The Times of Israel: Israel expands vaccination campaign to teens ages 16-18
COVAX announces new agreement, plans for first deliveries
The COVAX Facility has announced the signing of an advance purchase agreement for up to 40 million doses of the Pfizer/BioNTech COVID-19 vaccine.
COVAX is on track to deliver at least 2 billion doses of COVID-19 vaccines by the end of the 2021, including at least 1.3 billion doses to 92 lower income countries.
For more information please follow the link below:
Gavi: COVAX announces new agreement, plans for first deliveries
ATAGI advice on influenza and COVID-19 vaccines
The Australian Technical Advisory Group on Immunisation (ATAGI) have published advice related to the administration of influenza and COVID-19 vaccines.
Due to a lack of safety and immunogenicity data on the co-administration of these vaccines, it is therefore recommended that influenza and COVID-19 vaccines are not administered on the same day, but with a minimum interval of 14 days. There is no preference regarding the order of vaccine administration, noting that both the Oxford/AstraZeneca and Pfizer/BioNTech COVID-19 vaccines require a 2-dose schedule. If influenza and COVID-19 vaccines are inadvertently administered on the same day or are administered within a shorter timeframe than 14 days, revaccination with either vaccine is not recommended.
To read the advice in full, refer to the link below:
ATAGI advice on influenza and COVID-19 vaccines