IPPF COVID Guidance

The IPPF COVID-19 Task Force has developed a new guidance sheet for Member Associations on vaccine preparedness. There is a plethora of new vaccines at varying stages of approval. The Covid Taskforce has drafted a document to help Member Associations navigate the available information.

As of January 25 2021, a total of nine vaccine candidates have received authorization (emergency use or regulatory approval) for use in countries across the world. Of these nine, three are the most widely available and have data on safety and efficacy in the public domain. In addition, it is expected that the three vaccines (and one additional candidate from India) are the ones likely to be available in volumes across multiple countries to meet the demand.

Pfizer BioNTech vaccine: Also known as “Comirnaty”, a MRNA vaccine developed by Pfizer and BioNTech. The vaccine is given as an intramuscular injection in two doses 21 days apart (in trials, national protocols may vary). Comirnaty generates an immune response against SARS-CoV-2, the virus that causes COVID-19, by encoding a mutated form of the full spike protein of the virus.

This vaccine has also received a WHO emergency use validation2, enabling Unicef and PAHO to procure the vaccine and allows for countries that don’t have a regulatory body to speed up approvals based on this emergency use validation. Additional information on the relevance of the WHO Emergency use listing is given under “Related info & news” below. Although 50 million doses were expected to be delivered in 2020, Pfizer has run into challenges and has delayed supplies to many countries, most notably the EU. This is an evolving situation and we will like have updates in the late January/early February 2021.

This was the first approved C-19 vaccine in the world. List of countries where approved (as of Jan 21 2021) are United Kingdom, Bahrain, Canada, Mexico, US, Singapore, Costa Rica, Ecuador, Jordan, Panama, Chile, Oman, Saudi Arabia, Argentina, Switzerland, Kuwait, EU, Philippines, Pakistan, Colombia, Iraq, Israel, Qatar, Singapore, United Arab Emirates, Faroe Islands, Greenland, Iceland, Malaysia, Norway, Serbia.

Related info & news:

Press release from Pfizer: https://www.pfizer.com/news/press-release/press-release- detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine

Safety and efficacy data published in NEJM (interim analysis):

https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

WHO Interim Guidance on Emergency Use Listing of the Pfizer- BioNTech vaccine against Covid-19: https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines- SAGE_recommendation-BNT162b2-2021.1

1. Source of information: https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker 2. Moderna and COVID-19 Vaccine AstraZeneca vaccines are likely to seek WHO Emergency Use Listing in the coming months subject to these manufacturers working with WHO to seek this Emergency Use Validation.

Moderna vaccine: This is also a mRNA based vaccine that generates an immune response by containing a code for the spike protein of the SARS-Co-V-2. Developed by Moderna, BARDA, NIAID (USA), this vaccine is given as two doses 28 days apart as an injection. Similar to the Pfizer- BioNTech vaccine, it is given as two doses four weeks apart as an intramuscular injection. However, it is different from the above in that it does not require an ultracold chain and can be stored at 2–8 °C (shorter expiry).

Although a large number of doses have been ordered by many countries (over a billion doses in total) it is unclear as to the timelines for delivery for the different countries given that the vaccine is being manufactured only at two sites currently (One in USA and another in Switzerland).

Related info & news:

Statement from NIH and BARDA on the Emergency use authorization by FDA: https://www.nih.gov/news-events/news-releases/statement-nih-barda-fda-emergency-use- authorization-moderna-covid-19-vaccine

Safety and efficacy of the Moderna vaccine (interim analysis) published in NEJM: DOI: 10.1056/NEJMoa2035389 (https://www.nejm.org/doi/full/10.1056/NEJMoa2035389)

Covid 19 vaccine from Astrazeneca: This is a vaccine that contains a common cold virus that is made to carry the code for the spike protein of the SARS-Co-V-2 virus causing COVID-19. The vaccine is most commonly offered in national schedules as two doses given 4 -12 weeks apart as an injection. Of note, this vaccine safety and efficacy was established through a pooled analysis of data from four trials conducted in the UK, Brazil and South Africa. There is another smaller trial of the vaccine that is currently on-going aimed at providing data on safety and efficacy for HIV positive individuals. This vaccine is being manufactured at a number of sites across the world, with the Serum Institute of India being a key player aimed at producing close to 1 billion doses in total with 400 million doses of this being made available before end of 2021.

It is significant to note that this vaccine will likely be shipped to South Africa by April 2021 and will likely be the first Covid-19 vaccine to be made available in Africa. As of January 21 2021, this vaccine has received authorization/ approval for us in UK, Argentina, El Salvador, Dominican Republic, India, Bangladesh, Mexico, Nepal, Pakistan, Brazil, Saudi Arabia, Iraq, Hungary, Thailand.

Please download the full guidance document:

You can also access the full set of technical guidance compiled by the COVID taskforce on topics like abortion, advocacy, delivery, gender: Technical Resources

To contact the COVID-19 Taskforce please send them an email on covid-19@ippf.org

Posted in COVID, News Archive

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