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Polio this week as of 6 January 2021 | ReliefWeb.

[News and Press Release] [Source: GPEI] [Posted: 8 Jan 2021] [Originally Published: 8 Jan 2021] [Origin: View original]

The COVID-19 pandemic has triggered a deep global health and economic crisis. The Polio Oversight Board (POB) remains steadfast in its resolve to secure a polio-free world, while reaffirming its commitment that polio-funded assets are at the service of countries to respond to this public health emergency, especially in the critical next phase of COVID-19 vaccine introduction and delivery. Read more on the last POB statement of 2020.

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):

  • Pakistan: one WPV1 case, seven WPV1 and 16 cVDPV2 positive environmental samples Benin: one cVDPV2 positive environmental sample

  • Chad: one cVDPV2 case Cote D’Ivoire: three cVDPV2 cases

  • Democratic Republic of the Congo: one cVDPV2 case

  • Mali: one cVDPV2 positive environmental sample


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UNICEF Buys $80 Million Worth of Polio Vaccines | Precision Vaccinations.

[January 8, 2021 • 9:27 am CST]

(Precision Vaccinations)

South Korea-based LG Chem announced on January 7, 2021, that it had signed a contract with UNICEF to supply US$80 million worth of the polio vaccine Eupolio from 2021 to 2022.  The company stated it would supply the vaccine to 70 countries in the Middle East, Africa, and Southeast Asia.

LG Chem received the world's first prequalification approval for Eupolio as a Sabin IPV vaccine in December 2020.

The U.S. CDC recommends that children get polio vaccine to protect against polio or poliomyelitis. The CDC recommends that children get four doses of the polio vaccine, and children who will be traveling to a country where the risk of getting polio should complete the series before leaving for their trip.

The inactivated polio vaccine is the only polio vaccine that has been given in the United States since 2000.


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Press Release: LG Chem to Contribute to Global Polio Eradication with Eupolio™, the First Sabin Inactivated Polio Vaccine to Receive WHO Prequalification | Business Wire.

[January 07, 2021 08:30 AM Eastern Standard Time]

LG Chem Sabin-Inactivated Polio Vaccine (Sabin-IPV) Eupolio™ (Photo: Business Wire)

SEOUL, South Korea--(BUSINESS WIRE)--LG Chem announced today that its Sabin-Inactivated Polio Vaccine (Sabin-IPV) Eupolio™ received World Health Organization (WHO) prequalification effective December 21st, 2020, enabling it to be supplied globally as early as this month.

WHO prequalification of Eupolio™ is a major milestone in ongoing efforts towards global polio eradication, as it will help close the gap between demand and supply of safe and effective Inactivated Polio Vaccine (IPV) for millions of infants in need of immunization against poliovirus.

Eupolio™ is the first Sabin-IPV to obtain WHO prequalification. The main advantage of using attenuated Sabin poliovirus strains in the production of IPV is that there is a lower biosafety risk compared to wild-type polioviruses used to manufacture conventional IPVs, which has the potential to pose a biosafety hazard in case they escape from the manufacturing facility.

LG Chem initiated the development of Eupolio™ in 2014 and invested in the construction of a state of the art WHO Global Action Plan III compliant manufacturing facility in Osong, Korea. Eupolio™ demonstrated excellent phase III results in 2019, inducing high antibody titers against both wild-type and Sabin polioviruses, which will also protect against circulating vaccine-derived polioviruses (cVDPV) that make up the majority of polio cases in recent years.

Despite global efforts to eradicate poliovirus, more cases are being reported, with its international spread declared as a Public Health Emergency of International Concern by the WHO Director-General since 2014. The situation has been exacerbated by a global shortage of IPV, where many countries have not been able to introduce IPV in their routine immunization programs as recommended by WHO.

“LG Chem will facilitate the polio endgame by delivering the much-needed doses to infants in need of safe and effective polio vaccines,” said Ji-woong Son, Head of Life Sciences at LG Chem, “and will continue to contribute to improve global health by ensuring global accessibility of such essential vaccines.”

LG Chem developed Korea's first recombinant hepatitis B vaccine, Euvax™, and has since supplied it to more than 80 countries worldwide for the past 20 years. It has consistently invested in R&D to also develop the pentavalent vaccine, Eupenta™, which was prequalified in 2016. Development of Eupolio™ was supported by the Bill & Melinda Gates Foundation, with an extended partnership to develop a hexavalent combination vaccine, total awarded grants amounting to USD 57.6 Million. LG Chem’s hexavalent vaccine currently in clinical phase II is designed to prevent diphtheria, tetanus, pertussis, hepatitis B, haemophilus influenza type B, and polio, and aims to launch in 2024.

About LG Chem Life Sciences.

LG Chem Life Sciences is a business division within LG Chem, engaged in the development, manufacturing, as well as commercializing pharmaceutical products globally. LG Chem Life Sciences seeks to expand and make global presence by focusing on key core therapeutic areas of Immunology, Oncology, and Metabolic Diseases (specifically, diabetes and related metabolic diseases). To achieve such, its strategy is to actively pursue global collaboration encompassing from asset-centric to strategic investment and collaboration.

Contacts.

General Inquiries: contact.cbl@lgchem.com
Partners: partners.cbl@lgchem.com
Media (Jiin Chung): media.cbl@lgchem.com


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India: Ensure oral polio vaccine for children on Jan 17, says Harsh Vardhan | Outlook Magazine.

[08 JANUARY 2021 Last Updated at 5:09 PM | SOURCE: PTI]

Chennai, Jan 8 (PTI) Children below five years of age should be administered oral polio vaccine on January 17 and parents should ensure it, Union Minister for Health and Family Welfare, Harsh Vardhan said here on Friday.

Recalling the last case of polio virus in the country, exactly 10 years ago during January 2011 in West Bengal, he said the World Health Organisation certified India as polio free in 2014.

"Today, in spite of the fact that virtually all the countries in the world have eradicated polio, two of our neighbouring countries still have cases of the poliomyelitis, the P1 strain and the number is significant," he told reporters after overseeing the dry run for the rollout of COVID-19 vaccination at Rajiv Gandhi Government General Hospital here.

The Minister, however, did not specify the two countries.

According to the WHO''s website on polio section, only three countries in the world have never stopped transmission of polio, which are Pakistan, Afghanistan and Nigeria.

Considering the prevalence of the contagion in nearby countries, there is a risk factor and the National Expert Group on Immunisation in consultation with international health authorities have taken into account such factors.

"We have decided that on January 17, we are going to have our national immunisation days for polio which will run for two to three days," he said adding the drive covered aspects like identifying and immunising children left out from vaccination.

The vaccination is very essential to ensure that the nation maintained overall immunity levels against polio virus, he said.

"We have to once again ensure that 100 per cent children less than five years accompanied by their parents should receive two drops of oral polio vaccine on that day."

He exuded confidence that the country with its competence and long experience on administering vaccines would perform well on polio vaccine too.

Vardhan requested NGOs and volunteers of the National Cadet Corps (NCC) and National Service Scheme (NSS) to pitch in for the smooth ''conduct of COVID-19 vaccination,'' expected soon and for mobilisation of beneficiaries.PTI VGN SS / PTI PTI

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Disclaimer :- This story has not been edited by Outlook staff and is auto-generated from news agency feeds. Source: PTI


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Opinion: John P. Moore: How do you take your vaccine—one lump or two? | The BMJ.

[January 6, 2021]

The gradual rollout of the Pfizer and Moderna mRNA vaccines and the likelihood of additional approvals in the coming months provide hope for bringing the covid-19 pandemic under control in the USA during 2021. However, it is difficult to immunise many millions of people, particularly as mRNA vaccines are logistically complex to transport, store, and administer. With infection, hospitalisation, and death rates in the US as high as ever, we need to successfully immunise as many people as possible, as soon as possible. Accordingly, there are proposals to change the FDA-approved vaccine regimens to try to increase the number of people protected, specifically by halving the number of vaccine doses given to each person. I think doing this would be imprudent.

The mRNA vaccines are given in two doses either three (Pfizer) or four (Moderna) weeks apart. Placebo-controlled efficacy trials proved that these procedures confer ~95% protection. The data were reviewed by the FDA’s independent experts, leading to Emergency Use Authorizations last month. The argument to now use only one vaccine dose is based on data sets in the FDA briefing documents showing that rates of infection in the vaccine and placebo groups start to diverge ~10-14 days after the first dose, before the second dose is given. The Moderna document states: “There appears to be some protection against covid-19 disease following one dose.” The Pfizer document says that vaccine efficacy after one dose was 52.4% (95% Confidence Intervals 29.5%, 68.4%), while the corresponding value for Moderna was 80.2% (95% Confidence Intervals 55.2%, 92.5%). However, there is an important caveat in the Moderna document: “The small, non-random samples and short median follow-up limits the interpretation of these results”. And both briefing documents state that the available data “cannot support a conclusion on the efficacy of a single dose of the vaccine”. Given the importance of making evidence-based decisions, this is not a comment that should be ignored. 

Another notable comment appears in the Moderna document: “These data do not provide sufficient information about longer term protection beyond 28 days after a single dose.” In short, we do not know for how long any benefit of a single dose might persist. It is widely thought that mRNA vaccines confer protection by inducing virus neutralizing antibodies (NAbs). An important measure of vaccine performance is the NAb titer in the recipients’ sera. NAb responses to the Pfizer and Moderna vaccines are weak after the first dose but strongly boosted by the second. About half of the recipients have no detectable NAbs after the first dose of the Pfizer vaccine, but the mean titer in adults aged 18-55 increases from 14.4 to 360.9 after the second dose (Figure 6 of the FDA briefing document). For Moderna, the corresponding titer increase is from 18.2 to 343.8. The boosting effect of the second dose can be seen graphically here, as can the variable and transient nature of the NAb response to the first dose. Overall, the second mRNA vaccine dose increases antibody titers by ~20 to 30-fold, and perhaps as much as 100-fold when technical aspects of the assay read-out are factored in.

Antibody titers to the mRNA vaccines gradually diminish over time. We do not yet know what the decrease will be over the long-term, and nor do we know when the extent of the drop will reduce vaccine efficacy. It is reasonable to assume, however, that the stronger the initial degree of protection (i.e., NAb titers), the longer it will be sustained. I am not confident a single dose mRNA vaccine would be effective for long enough; a regimen that only worked for a short period would be of limited value to individuals or populations. A similar problem arises if the interval between the two doses were extended to allow more people to receive their partially protective first dose sooner. Some flexibility in timing the second dose would be appropriate, but vaccine failures will surely increase with the length of the delay. Would uptake take a hit if there are multiple reports of vaccine failures among at-risk individuals? That would be contrary to the goal of the one-shot concept. It would also be highly problematic if individual recipients of a single vaccine dose felt protected and increased their infection risk by behaving differently. Furthermore, there is a risk that poorly protective antibody response could drive the emergence of resistant variants in infected vaccine recipients. Already, viral variants with mutations that are suspected to confer some resistance to human antibodies are circulating. Large populations of inadequately immunized individuals provide an ideal environment for the enrichment and further evolution of these variants. The consequences to the overall vaccine effort would be very serious if this happened.

It could be hard to persuade the public to switch to an inferior, one-dose regimen. Asking individuals to reduce their own protection for the sake of protecting a stranger requires quite a degree of altruism. Clearly, some people would choose to do that, but many will not be so selfless about helping others. Predictable controversies are best avoided, particularly given the need to elevate public confidence in vaccines and maximize their use. 

In the USA, the FDA has come out strongly against any changes to the approved ways to administer the Pfizer and Moderna vaccines. I agree with the position it has taken. The UK has taken a different perspective, recommending delaying the second dose of the Pfizer and AstraZeneca and even allowing different vaccines to be used for each dose in “extremely rare occasions”. The clinical trial evidence to support these new policies is flimsy or non-existent, so there are real risks involved. The WHO have said that there is no scientific evidence for  delay of more than six weeks in administering the second dose of the Pfizer vaccine, although they understand why the UK might consider this given the rise in covid-19 cases. 

Are there better options that the UK should consider instead of the dose-delay strategy? An alternative way to double the number of people immunized is to halve the amount of vaccine given in each of the two doses. Here, there is some support based on dose-ranging studies in the Phase 1 trials of the Pfizer and Moderna vaccines. Extrapolating from the data for the approved doses (30 µg and 100 µg, respectively) suggests that halving the dose would reduce the NAb titers by ~2-3 fold, a much smaller decrease than is the case when only a single full-dose is given. While there can be no certainty that efficacy would be unaffected, this strategy seems to be a safer option than dropping, or seriously delaying, the second dose. It should be noted, however, that the FDA has also rejected this option for use in the USA, for reasons that I agree with.

One scenario where a one-dose regimen could be valuable involves people who have recovered from Covid-19 and who now wish to be vaccinated. A single vaccine dose may provide a sufficient boost to their infection-induced and already substantially protective antibodies. The data on this idea may already exist from the completed clinical trials, as some previously infected participants were vaccinated. If not, it could be tested by monitoring the antibody responses in convalescent people who are now receiving the approved vaccines. As 20 million Americans and nearly 3 million Britons are already known to be infected, a substantial number of vaccine doses could be saved if each of them required only one. Testing this idea clinically by measuring antibody titers in a few tens of people would not be onerous.

It is in everyone’s interests to successfully immunize as many people as we can, and as soon as the vaccines become available. Creative thinking on how to improve the process is certainly appropriate. However, it would be best to consider all aspects of what is involved, followed by a data-driven and transparent decision-taking process. The mounting controversy in the U.K. over poorly explained and arguably ill-judged decisions on how best to use the approved vaccines is something best avoided.

John P. Moore is a professor of microbiology and immunology involved in vaccine research at Weill Cornell Medicine in New York City.

Competing interests: none declared


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Opinion: Covid-19 vaccines: to delay or not to delay second doses | The BMJ.

[January 5, 2021]

The importance of successful vaccination strategies in controlling the covid-19 pandemic cannot be overstated and should be vigorously endorsed. Equally critical is that vaccines’ proven to be effective in a particular dosing schedule are not altered without solid scientific support or evidence. Two covid-19 vaccines, (from Pfizer/BioNTech and AstraZeneca/Oxford) recently approved for emergency use in the UK have a defined time scheduled two doses for use. Due to the accelerating pandemic and a desire to maximise the numbers in the population to receive a first dose vaccine, the Joint Committee on Vaccines and Immunization (JCVI) has proposed changing the dose schedules by considerably extending time to the second booster dose. The proposal has been supported by the UK Chief Medical Officers (CMOs) who indicated there are vaccine shortages across the UK. This is disputed by vaccine manufacturers.

The Pfizer/BioNTech vaccine is the first human mRNA vaccine evaluated in a phase 3 clinical trial. The study was a well-designed, prospective randomised controlled trial with blinded endpoint assessment. [1] It was well powered, reporting on 37,706 individuals at 152 sites in six countries who received vaccine or placebo and had median follow-up of 2 months. The overall results showed an efficacy of 95% reduction in covid-19 cases at least seven days after the second dose, which was delivered to a scheduled 21-day interval between the 1st and 2nd dose. Sub-group analyses confirmed similar vaccine efficacy among subgroups including patient age.

The JCVI advice and the CMO’s decision to delay the second dose to between 4-12 weeks is not based on data from the trial, but on an assumption of what would have happened if the second dose hadn’t been given at 21 days. While assumptions can be useful for generating a hypothesis, alone they are not a sufficient reason to alter a known effective dosing regimen. 

There are also no data on how long a first single dose of the mRNA generated immunogen (the virus Spike protein) induces a clinically effective immune response, comprising T cells, B cells, and their memory cells. [2] A crucial point is that the Pfizer vaccine uses mRNA.  Non-replicating mRNA (basic structure used in the two covid-19 vaccines- Pfizer/BioNTech and Moderna) after injection into the body becomes quickly degraded by extra and intracellular enzyme systems (RNAases). Modifications have been introduced, to improve the delivery and survival of the mRNA vaccines, including as in the Pfizer/BioNTech vaccine, enveloping the mRNA in lipid nanoparticles (LNP-mRNA). How well the LNP-mRNA survives after a 1st injection and induces durable human immune responses is unknown. [3-5] Animal models using LNP-mRNA vaccines against the virus show that ~28 days after a 1st injection, correlates of virus neutralising antibody production fall off markedly (suggesting limited survival and stimulation by the vaccine mRNA and its’ encoded Spike immunogen). However, the specific anti-viral immune response was strongly boosted with a 2nd injection of vaccine. [6] This raises concerns that extending a 2nd injection out to beyond 28 days could compromise vaccine efficacy. Human studies are urgently needed, ideally before pursuing the delayed 2nd dose strategy. The time interval for a mRNA booster may be very critical for getting the best sustained immune response. mRNA vaccines have never been used in late stage human trials before 2020 and the only data we have are from the Pfizer/BioNTech and the Moderna (another mRNA vaccine) studies, which use different vaccines at different concentrations. 

Furthermore, given that the Pfizer/BioNTech vaccine is scheduled to be delivered to 3-10 million vulnerable adults or health and social care workers exposed to high levels of risk, the JCVI/CMOs appear to be advocating what could prove to be a major change with attendant clinical risk (eg less efficacy than that generated by Pfizer/BioNTech study). The MHRA has approved and international expert bodies have advised using the existing study dosing schedule. The Centre for Disease Control in the USA has stated that for both mRNA vaccines (Pfizer/BioNTech & Moderna) “The second dose should be administered as close to the recommended interval as possible” – i.e. 21 days and 28 days respectively. [7] The World Health Organization has also advised that the Pfizer/BioNTech vaccine should be given “according to the following schedule: a single dose followed by a second dose 21 days later.” [8]

Maximising coverage with the 1st dose as intended by the CMOs could come at increased risk to already high risk/priority groups.  At a minimum, if the UK remains intent on pursuing this time extension to the second dose, the following should be implemented: 

Firstly, the second dose should continue to be provided at 21 days until the MHRA and/or JCVI make the data on which the JCVI recommendation is based publically available for independent scientific review. 

JCVI’s hypothesis that 50-60% efficacy with one dose is better than 95% efficacy for half the number of individuals with the MHRA approved dosing is, as far as we know, based on an assumption. However, if following a single dose there was a substantial decrease in efficacy during days 21-84, then the number of lives saved and hospital admissions avoided may be less than with the 21-day second dose schedule, for which we have efficacy results. Just as critical, the secondary immune response from a delayed dose at 84 days and any impact on the duration of immunity is unknown. 

Secondly, if the delay in the second dose is implemented then rigorous RCTs comparing the 21-day and delayed second dosing schedule should be conducted to rapidly ensure evidence-based future vaccination policy.    

The vaccine used in the Oxford/AstraZeneca study is a different type of vaccine (viral vector DNA) for which there are prior data from other similar vaccines. [8,9] In these circumstances, there is a valid argument to support delaying the second dose of this vaccine if there is not sufficient supply of the vaccine and the balance of public health risks warrants this. If JCVI’s advocacy for a dose delay has been based on unpublished research data and current modelling, such data should be immediately made available in the public domain for adequate peer reviewed scrutiny. 

John FR Robertson, Professor of Surgery & Consultant Surgeon, University of Nottingham. 

Herb F Sewell, Emeritus Professor of Immunology & Consultant immunologist, University of Nottingham.

Marcia Stewart, Social Care professional & emeritus academic, De Montfort University.

Denise Kendrick, Professor of Primary Care Research and General Practitioner, University of Nottingham.

Raymond M Agius, Emeritus Professor of Occupational Medicine, University of Manchester, Manchester.

Declaration of interest: All authors are current or intended recipients of covid-19 vaccines. HFS has served on UK Medicines Commission from 2002-2006. He has a doctor as a family member.

Acknowledgement: Professor Sheila M. Bird OBE FMedSci FRSE Formerly Programme Leader at MRC Biostatistics Unit, Cambridge Institute of Public Health; for her helpful comments and discussions about prospective RCTs and delayed covid-19 vaccine doses (see reference 10).

[See source article for References]


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Covid-19 vaccination: What’s the evidence for extending the dosing interval? | The BMJ.

[Published 06 January 2021]

On 30 December the four UK chief medical officers announced that the second doses of the covid vaccines should be given towards the end of 12 weeks rather than in the previously recommended 3-4 weeks. Gareth Iacobucci and Elisabeth Mahase look at the questions this has raised

Why has the government taken the step to delay the second dose?

In a letter sent to healthcare staff on 30 December NHS England said the decision had been taken to prioritise giving the first doses of vaccine (whether the Pfizer and BioNTech one or that of Oxford University and AstraZeneca) to as many people as possible on the priority list to “protect the greatest number of at-risk people overall in the shortest possible time.”1 Delaying the second dose meant that the prioritisation process “will have the greatest impact on reducing mortality, severe disease and hospitalisations and in protecting the NHS and equivalent health services,” it said.

Why was this decision taken?

In a letter to the profession sent on 31 December laying out the “scientific and public health rationale” for the change to the dosing schedule,2 the chief medical officers said that vaccine shortages were a major reason for the shift in approach. “We have to ensure that we maximise the number of eligible people who receive the vaccine. Currently the main barrier to this is vaccine availability, a global issue, and this will remain the case for several months and, importantly, through the critical winter period. The availability of the AZ [AstraZeneca] vaccine reduces, but does not remove, this major problem. Vaccine shortage is a reality that cannot be wished away.”

What’s the evidence for changing the schedule?

There isn’t much for the Pfizer-BioNTech vaccine, as trials did not compare different dose spacing or compare one with two doses. The trials of the Oxford-AstraZeneca vaccine did include different spacing between doses, finding that a longer gap (two to three months) led to a greater immune response, but the overall participant numbers were small. In the UK study 59% (1407 of 2377) of the participants who had two standard doses received the second dose between nine and 12 weeks after the first. In the Brazil study only 18.6% (384 of 2063) received a second dose between nine and 12 weeks after the first.3 The combined trial results, published in the Lancet,4 found that vaccine efficacy 14 days after a second dose was higher in the group that had more than six weeks between the two doses (65.4%) than in the group that had less than six weeks between doses (53.4%).

In their joint statement the chief medical officers said that data provided to the Medicines and Healthcare Products Regulatory Agency (MHRA) showed that, although optimal efficacy was achieved through two doses, both vaccines “offer considerable protection after a single dose, at least in the short term.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said, “In an ideal world, decisions about treatments would only be made within the exact parameters of the trials which have been conducted. In the real world, this is never so . . . We know that vaccinating only half of a vulnerable population will lead to a notable increase in cases of covid-19, with all that this entails, including deaths. When resources of doses and people to vaccinate are limited, then vaccinating more people with potentially less efficacy is demonstrably better than a fuller efficacy in only half.”

[Continue reading in source article]


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