UK authorises Pfizer/BioNTech COVID-19 vaccine

Following a thorough analysis of data produced from rigorous clinical trials, the independent Medicines and Healthcare products Regulatory Agency (MHRA) in the UK have concluded that the Pfizer/BioNTech COVID-19 vaccine meets the strict standards of safety, quality and effectiveness required. As such, the UK government has announced it's approval with plans to make the vaccine available from as early as next week. Final advice on priority groups is still being determined by the Joint Committee on Vaccinations and Immunisations (JCVI).

To read the press release please refer to the link below:

UK authorises Pfizer/BioNTech COVID-19 vaccine


TGA COVID-19 resource hub

The Therapeutic Goods Administration (TGA) have developed a dedicated COVID-19 resource hub to host information for consumers, health care professionals and sponsors. This hub details the COVID-19 vaccine approval process for Australia, common questions relating to COVID-19 vaccine safety, quality and effectiveness, as well as the regulatory processes and requirements.

To view this page please follow the link below:

Therapeutic Goods Administration: COVID-19 vaccines

 


Aljazeera: COVID-19 vaccines explained in maps and charts

The following article gives an overview of the various vaccine platforms being utilised to develop a COVID-19 vaccine, and outlines which vaccines are currenly in human trials.

To read more follow the link below.:

Aljazeera: COVID-19 vaccines explained in maps and charts


MMWR: The Advisory Committee on Immunization Practices' Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine - United States, 2020

Once a COVID-19 vaccine has been approved for use, it is expected that the initial supply will be limited. The Advisory Committee on Immunization Practices (ACIP) in the United States, has published it's approach for recommending and allocating COVID-19 vaccines to the American population. In addition to scientific data, decisions on the allocation of COVID-19 vaccines will be based around 4 ethical principles. These include: the need to maximise benefit and minimise harm, promote justice, mitigate health inequities and promote transparency.

To read the article in full, please see the link below:

MMWR: The Advisory Committee on Immunization Practices' Ethical Principles for Allocating Initial SUpplies of COVID-19 Vaccine - United States, 2020


The Lancet - Emergency use authorisation for COVID-19 vaccines: lessons from Ebola

In order to increase public acceptance of an emergency use authorisation for COVID-19 vaccines, the following article in The Lancet suggests that lessons can be learnt from previous experiences with Ebola virus vaccines in Guinea and the Democratic Republic on the Congo.

Emergency use authorisation allows the public to access promising medicinal products prior to licensing and registration. In the setting of a public health emergency, their use may be ethically justified if certain conditions are met.

By having a transparent evaluation process, ensuring that it meets a favourable benefit-risk ratio based on quality and safety data, and having an accountable system of regulatory oversight and monitoring, the ethical quality and overall acceptance of a COVID-19 vaccine can be improved.

To read more follow the link below:

The Lancet - Emergency use authorisation for COVID-19 vaccines: lessons from Ebola


The Conversation: Moderna’s COVID vaccine reports 95% efficacy

The American biotech company Moderna has released early data from phase III clinical trials, announcing that its COVID-19 vaccine has an efficacy level of 94.5%.

Like Pfizer's vaccine, the Moderna vaccine is also an mRNA (messenger RNA) vaccine, however will be easier to distribute as its temperature requirements are 4℃ for 30 days (rather than -70℃ as in the case of the Pfizer vaccine); and for storage requirements beyond 30 days it needs to be kept at -20℃.

The stage III trial involved 30,000 participants, out of those 95 people developed COVID-19 in the week after the final vaccination, with 90 of those being in the placebo group and only 5 in the group who received the COVID vaccine.

It is unknown how long protection from this vaccine lasts and how effective it is in the elderly, pregnant women or those with a chronic illness; however, in results Moderna published in September the vaccine produced a similar amount of antibodies in adults over 70 as adults under 70 years of age. It did however induce fewer T cells in people aged over 71, so at this stage it is not know whether this will result in lower protection or shorter lasting immunity in the elderly.

Read more via the link below:

The World Health Organization: How do vaccines work?

The World Health Organization have developed a new resource explaining how vaccines provide immunity.

To view the resource please follow the link below:

The World Health Organization: How do vaccines work?

 


The New York Times: The Husband-and-Wife Team Behind the Leading Vaccine to Solve Covid-19

BioNTech, a German-based biotechnology company with a focus on developing cancer therapies, previously predicted that messenger-RNA technology could be used to rapidly develop a vaccine in the event of a pandemic.

The company, founded by Dr Ugur Sahin and Dr Ozlem Tureci, in partnership with Pfizer, announced this week that their COVID-19 vaccine candidate is more than 90% effective.

To read more, please follow the link below:

The New York Times: The Husband-and-Wife Team Behind the Leading Vaccine to Solve Covid-19


BBC: Covid vaccine - First 'milestone' vaccine offers 90% protection

Vaccine developers Pfizer and BioNTech have announced preliminary data shows their COVID-19 vaccine is demonstrating 90% effectiveness. The vaccine has been tested on over 43,000 people in six countries (USA, Germany, Brazil, Argentina, South Africa and Turkey). They are planning to apply for emergency approval so the vaccine can be in use by the end of November.

Requiring two doses three weeks apart, the vaccine has been developed using an mRNA platform. Scientists take part of the virus’s genetic code and coat it in a lipid so that it can enter the body’s cells resulting in the production of the coronavirus spike protein, prompting the immune system to produce antibodies and T-cells to kill the infected cells. If the person who has been immunised encounters the virus, the antibodies and T-cells are then activated to fight the virus.

It is not known how effective the vaccine will be in elderly people as yet or how long immunity will last. This vaccine is not without manufacturing and logistical challenges, as mRNA vaccines need to be stored at minus 80 degrees Celsius. To date, no major safety issues have been identified.

Read more about this via the link below:

BBC: Covid vaccine: First 'milestone' vaccine offers 90% protection