nOPV2 Polio Vaccine For 2022
The nOPV2 polio vaccine is derived from the live, infectious virus, but it has been 'triple-locked' using genetic engineering to prevent it from becoming harmful. As a result, nOPV2 is genetically more stable than existing OPV, with a lower risk of reversion to neurovirulence. nOPV2 is deployed under WHO's Emergency Use Listing procedure (EUL) to enable rapid field availability. nOPV2's performance in the field is closely monitored in line with EUL standards, and data collection continues with the ultimate goal of WHO prequalification and full licensure.
nOPV2 vaccine was developed as attenuated serotype two polioviruses derived from a modified Sabin 2 infectious cDNA clone. OPV2 Candidate 1 (S2/cre5/S15domV/rec1/hifi3) and nOPV2 Candidate 2 (S2/S15domV/CpG40) were generated by modifying the Sabin-2 RNA sequence to improve phenotypic stability and make the strains less prone to reversion to virulence.
The Lancet published a study on December 9, 2020, that concluded 'novel OPV2 candidates were as safe, well-tolerated, and immunogenic as monovalent OPV2 in previously OPV-vaccinated IPV-vaccinated adults. these data supported the further assessment of the vaccine candidates in children and infants.'
A research study published in npj Vaccines on February 11, 2022, confirms that the nOPV2 is more stable against virulent mutations than the licensed OPV2. This study directly assesses shed nOPV2 virus against shed OPV2 virus in comparable groups. Furthermore, it shows that the attenuated nOPV2 vaccine is more resistant to reversion than OPV2. Furthermore, in April 2022, the WHO's SAGE noted the safety and genetic stability data on novel OPV2 (nOPV2), confirming the genetic stability of the vaccine.
The GPEI published nOPV2 Frequently Asked Questions and Fact Sheet. And the WHO Listed the nOPV2 vaccine (Bio Farma, Indonesia) for emergency use on November 13, 2021, to address the rising cases of a vaccine-derived polio strain in several African and East Mediterranean countries. On March 30, 2022, the GPEI released an updated version of the Standard Operating Procedures to guide any country's management that detects poliovirus outbreaks. Global Circulating Vaccine-derived Poliovirus (cVDPV) outbreak country list as of April 26, 2022.
Bio Farma, located in Jakarta Selatan 12190, Indonesia, is one of about 29 vaccine manufacturers in 22 countries worldwide that have obtained the World Health Organization Prequalification. The mOPV1 vaccine contains a suspension of type 1 attenuated poliovirus.
Since the nOPV2 launch in March 2021, over 350 million doses have been administered across 18 countries by late May 2022. The majority of countries using the vaccine have also managed to stop the transmission of cVDPV2. In addition to those who have already rolled out the new vaccine, 16 other countries are also verified as ready to use nOPV2 by GPEI, and a further 17 are in the midst of preparations.
The nOPV2M4a Polio Vaccine is indicated to prevent circulating vaccine-derived polio-virus (cVDPV) polio cases. Most cases of cVDPV are caused by mutations in a strain of poliovirus called type 2. the novel vaccine will eventually be licensed based on three criteria: a similar safety profile to the currently licensed mOPV2 of the Sabin strain, non-inferior immunogenicity, and reduced reversion to virulence.
On April 24, 2020, the U.S. CDC stated 'Thirty-one ongoing and new cVDPV type 2 (cVDPV2) outbreaks were documented during July 2019–February 2020; nine episodes spread internationally. cVDPV2 outbreaks were often linked to poor coverage with monovalent Sabin oral poliovirus (OPV) type 2 during outbreak response campaigns. The Global Polio Eradication Initiative plans to introduce a genetically stabilized, novel OPV type 2 for outbreak response in mid-2020 and expand use in 2021. OPV use after certification of polio eradication will eliminate the risk of VDPV emergence.
nOPV2 Side Effects
Assessment of genetic changes and neurovirulence of shed Sabin and novel type 2 oral polio vaccine viruses.
nOPV2 News For 2021 - 2022
May 17, 2022 - Pakistan announced a nationwide polio vaccination campaign following the confirmation of three local polio cases.
April 28, 2022 - The polio outbreak in Tajikistan marked the first detection of cVDPV2 in the WHO European Region and is the first cVDPV2 outbreak in the world to be declared officially closed following supplemental immunization using the nOPV2 vaccine.
April 7, 2022 - The WHO's Strategic Advisory Group of Experts on immunization is convening in Geneva and will review updated data on novel oral polio vaccine type 2 (nOPV2) use and recommendations on initial planning for OPV cessation. The SAGE noted that a framework for a comprehensive analysis of nOPV2 performance is under development and requested periodic updates on the safety and genetic stability data of nOPV2.
March 21, 2022 - The U.S. CDC issued a Level 2 Alert regarding polio outbreaks in Asia and Eastern Europe.
March 18, 2022 - The WHO confirmed the first phase of the polio vaccination campaign targets 9.4 million children in Malawi, Mozambique, Tanzania, and Zambia. In which Zimbabwe will also take part, three subsequent rounds are set for April, June, and July 2022 and aim to reach over 23 million children with more than 80 million doses of the bivalent Oral Polio Vaccine recommended for wild poliovirus (type 1).
March 17, 2022 - PLOS One published a RESEARCH ARTICLE: Use of oral polio vaccine and the incidence of COVID-19 in the world. Conclusions: Countries using OPV have a lower incidence of COVID-19 compared to those using IPV. This might suggest that OPV may prevent SARS-CoV-2 infection at an individual level or slow down the transmission at the community level.
February 17, 2022 - "The last case of wild poliovirus in Africa was identified in northern Nigeria in 2016; globally, there were only five cases in 2021. However, any case of wild poliovirus is a significant event, and we will mobilize all resources to support the country's response," said Dr. Modjirom Ndoutabe, Polio Coordinator in the WHO Regional Office for Africa.
February 11, 2022 - The journal NPJ Vaccines published a study that concluded: The available data from a key target age group for outbreak response confirm the superior genetic and phenotypic stability of shed nOPV2 strains compared to shed Sabin-2 and suggest that nOPV2 should be associated with less paralytic disease and potentially lower risk of seeding new outbreaks.
February 10, 2022 - Djibouti's Public Health Minister, Dr. Ahmed Robleh Abdilleh, shared plans for vaccination campaigns and increased surveillance in response to the transmission of cVDPV2.
December 9, 2021 - The WHO confirmed it recommends that all travelers to polio-affected areas be fully vaccinated against polio. Residents (and visitors for more than four weeks) from infected areas should receive an additional dose of oral polio vaccine or inactivated polio vaccine within 1 to 12 months of travel.
November 23, 2021 - The WHO announced the polio Committee unanimously agreed that the risk of international spread of poliovirus remains a Public Health Emergency of International Concern and recommended the extension of Temporary Recommendations for three months.
November 3, 2021 - The BMJ reported that house-to-house polio vaccinations restarted in Afghanistan after a three-year pause, where polio cases have been reported.
November 3, 2021 - GPEI reported a summary of new WPV and cVDPV this week (AFP cases and ES positives): Cameroon: one cVDPV2 case; DRC: one cVDPV2 case; Niger: two cVDPV2 cases; Nigeria: eight cVDPV2 cases and five positive environmental samples.
November 1, 2021 - The U.S. CDC issued a Level 2 Travel Advisory that stated 'Destinations in Africa currently considered high risk for polio.'
October 26, 2021 - The WHO Africa posted an article: Pursuing the endgame: novel polio vaccine rollout in Africa.
October 22, 2021 - Africa News reported Ethiopia launched a polio vaccination campaign with type 2 novel oral polio vaccine (nOPV2) targeting over 17 million under-five children.
October 11, 2021 - Following a careful review of the safety and genetic stability data from mass immunization campaigns conducted with the novel oral polio vaccine type 2 (nOPV2), the Strategic Advisory Group of Experts on immunization (SAGE) today endorsed the transition to the following use phase for the vaccine. In addition, the WHO's independent Global Advisory Committee on Vaccine Safety and SAGE confirmed no major safety concerns associated with nOPV2 after reviewing data.
October 1, 2021 - Polio outbreak in Tajikistan - 31 children have been found to have polio caused by cVDPV2, and the virus has also been isolated from 26 children without paralysis. twenty environmental samples have tested positive for the presence of the virus. The detected polioviruses were linked to a virus strain currently circulating in Pakistan.
March 19, 2021 - The WHO reports that four paralytic children infected with circulating vaccine-derived poliovirus type 2 (cVDPV2) have been reported in Tajikistan, with several cVDPV2 cases detected in community and close contacts. n March 8, 2021, the detection of cVDPV2 cases in Tajikistan was reviewed by WHO and designated as a grade 2 emergency. OPV2 is a new tool that GPEI partners are deploying to better address cVDPV2. OPV2 is safe and provides comparable protection against poliovirus while being more genetically stable than monovalent oral polio vaccine type 2 and therefore less likely to revert into a form that can cause paralysis in under-immunized communities. This means that nOPV2 could help stop the spread of cVDPV2 outbreaks.
March 13, 2021 - nOPV2 will be rolled out in Africa to fight outbreaks of vaccine-derived poliovirus type 2. Such polio strains are rare but occur in under-immunized communities with limited access to safe water and sanitation.
November 13, 2020 - The World Health Organization's Prequalification program issued an Emergency Use Listing recommendation for the type 2 novel oral polio vaccine (nOPV2). This will allow the vaccine's rollout for limited initial use in countries affected by circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks.
October 29, 2020 - New polio vaccine, designed to prevent harmful mutations, is poised to get emergency WHO approval.
October 22, 2020 - The twenty-sixth meeting of the Emergency Committee under the International Health Regulations (2005) on poliovirus's international spread was convened. The Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine-derived polioviruses (cVDPV). The following IHR States Parties provided an update at the video conference or in writing on the current situation in their respective countries: Afghanistan, Chad, Egypt, Guinea, Pakistan, Somalia, South Sudan, Sudan, and Yemen.
July 29, 2021 - The journal Nature published the results of a study - Because of the safety, immunogenicity, and promising phenotypic stability of these viruses, nOPV2 use under Emergency Use Listing (EUL) features prominently in the Global Polio Eradication Initiatives' new strategy to stop further spread of cVDPV21, and the EUL has recently been granted for nOPV2-c1. The methods described here are now being applied to shed virus from paired phase 4 and phase 2 clinical trials of mOPV2 and nOPV2 in children and infants, allowing a more direct comparison of the molecular evolution and virulence of shed nOPV2 viruses with shed Sabin 2 in the age groups that will be the focus of outbreak responses.
July 13, 2019 - The safety and immunogenicity of novel live attenuated monovalent (serotype 2) oral poliovirus vaccines in healthy adults: a double-blind, single-center phase 1 study.
April 4, 2019 - The UNICEF Supply Division Team from Copenhagen came to Bio Farma to discuss the joint procurement of mOPV2 global stockpiling in a final product of 60 million doses or 3 million vials that must be prepared in 2019.
nOPV2 Clinical Studies
nOPV2 polio vaccine is in several clinical studies that are in various stages. clinical summaries for the nOPV2 vaccine.