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Beyond COVID-19: Vaccine makers shift their focus back on ways to cover lost ground in routine immunisation

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The World Health Organization (WHO) had reported last year that an estimated 23 million children under the age of 1 year did not receive basic vaccines, which is the highest number since 2009.

Since the beginning of the ongoing coronavirus pandemic, the entire world made COVID-19 and containing the notorious virus a priority. However, this prioritisation neglected other serious non-covid ailments and public health essentials like immunisation. Last month in a joint statement, WHO and UNICEF reported an increase in measles cases in January and February this year and warned that this is a sign of a “heightened risk for the spread of vaccine-preventable diseases and could trigger larger outbreaks, particularly of measles affecting millions of children in 2022.”

“Pandemic-related disruptions, increasing inequalities in access to vaccines, and the diversion of resources from routine immunization are leaving too many children without protection against measles and other vaccine-preventable diseases,” the global agencies said in a statement. The agencies are concerned that outbreaks of measles could also forewarn outbreaks of other diseases that do not spread as rapidly.

According to the World Health Organization (WHO), the routine immunisation coverage around the world dropped from 86 percent in 2019 to 83 percent in 2020. The global health agency had also reported last year that an estimated 23 million children under the age of 1 year did not receive basic vaccines, which is the highest number since 2009.

What happened in India?

Of those 23 million children, more than 60 percent live in just ten countries (India, Nigeria, the Democratic Republic of the Congo, Pakistan, Indonesia, Ethiopia, Brazil, Philippines, Angola, and Mexico) and 17 million of them did not receive any vaccines (zero-dose children), according to the UNICEF. The global agency, this substantial decline in coverage from 2019, has resulted in nearly 2 million more un- or under-vaccinated children compared to 2019. This decreased coverage was largely driven by coverage drops in India (6 percentage points), Pakistan (7 percentage points), and Nepal (9 percentage points). Consequently, DTP3 coverage in South Asia backslid to levels not seen since 2014.

According to WHO, at present, there are vaccines to prevent more than 20 life-threatening diseases and help people of all ages to live longer and healthier lives. Currently, immunisation prevents 3.5-5 million deaths from diseases like diphtheria, tetanus, pertussis, influenza, and measles every year. However, only 19 vaccine introductions were reported in 2020 which is less than half of any year in the past two decades. As a majority of the vaccine-makers were under stress to find right jab against COVID-19, the introduction of new non-COVID-19 vaccines was affected.

At present, Inactivated Polio Vaccine (IPV), Rotavirus vaccine (RVV), Measles-Rubella (MR) vaccine, Pneumococcal Conjugate Vaccine (PCV), and Tetanus and adult diphtheria (Td) vaccine are part of India’s Universal Immunization Programme (UIP) which was launched in 1985. These vaccines enhance protection against 12 vaccine-preventable diseases: Diphtheria, Pertussis and Tetanus, Polio, Measles and Rubella, Hepatitis B, Meningitis, Pneumonia caused by Hemophilus Influenza type B, Rotavirus diarrhoea, Pneumococcal Pneumonia, and Japanese Encephalitis.

‘Supply chain management of non-covid vaccines more affected’

However, due to pandemic-related disruption, there has been a worrying decline in routine immunisation, especially among children. Dr. Swapan Kumar Jana, Director -R&D and Manufacturing at Serum Institute of India Limited (SII) told Financial Express.com that the supply chain management of non-covid vaccines was more affected than the manufacturing process.

“I don’t think that manufacturing of non-covid vaccine got much impact but the supply chain management got very much affected. Also, critical raw materials which are manufactured in Germany and United States; their supply got affected during the pandemic which affected the overall supply of non-covid vaccine. During the beginning of the pandemic, COVID-19 was the focus of the government, non government organisations, and academic Institute. As far as our company is concerned even we’re not much affected because we had a lot of bulk stocks of raw material. Seeing the pandemic we are now accelerating in R&D and we are investing in proven technology based on the market dynamic to address the accessibility of all kind of vaccines,” Dr. Jana told Financial Express.com.

Meanwhile, some vaccine-makers claimed that pandemic didn’t had much impact on the manufacturing of non-covid vaccines.

“Sanofi India has taken necessary steps so that the pandemic doesn’t cause any logistic concerns in manufacturing of our non-COVID-19 vaccines. In fact, we ensured an uninterrupted supply of ShanIPV™, our injectable inactivated polio vaccine (IPV) that was delivered to the Government of India as per the agreed supply schedule. There were no supply challenges of our primary, booster, and the flu vaccine in the country. We have seen increased acceptance for flu vaccination especially for children (6 months -5 years) over and above booster doses for diseases as polio, diphtheria, tetanus, and pertussis.” Annapurna Das, Country Head, Sanofi Vaccines, India and South Asia told Financial Express.com.

Meanwhile, in India as the demand for COVID-19 vaccines are slowing down, the vaccine-makers have now started focusing on non-Covid vaccines. Last month, the domestic pharma industry has urged the Central Drugs Standards Control Organisation (CDSCO) to consider extending the fast-track approval process adopted during COVID-19 for vaccines to non-COVID vaccines and drugs too.

“Combination of detailed manufacturing planning and deployment of ancillary capacity for COVID-19 vaccine manufacturing has ensured no impact on the manufacturing process for non-COVID vaccines at BE,” Dr. Vikram Paradkar- Executive Vice President (Manufacturing), Biological E told Financial Express.com.

Upcoming non-covid vaccines

Reportedly, Bharat Biotech is now focusing on making vaccines for polio, rabies, which the company was making before the pandemic hit. Moreover, the vaccine maker is also working on setting up the manufacturing site for GSK’s plasmodium falciparum malaria vaccine (RTS,S/AS01E tentatively branded Mosquirix), which it is making for countries Africa.

In January last year, GSK, PATH, and Bharat Biotech announced the signing of a product transfer agreement for RTS,S/AS01E. The agreement includes the transfer of manufacturing of the RTS,S antigen part of the vaccine and the grant of a license on all rights pertaining to the RTS,S/AS01 malaria vaccine to BBIL. GSK will retain the production of the adjuvant of the vaccine (AS01E) and will supply it to Bharat Biotech.

According to the companies, RTS,S/AS01E is the first, and to date, the only malaria vaccine to have received a positive review by regulatory authorities (positive scientific opinion from the European Medicines Agency and approval by the regulatory authorities of Ghana, Kenya, and Malawi for use in the MVIP). The first dose of the vaccine has reached more than 500,000 children since the pilots were initiated by ministries of health in the three participating countries in 2019.

Meanwhile, SII is expecting that its malaria vaccine candidate will go into production by the end of this year. Additionally, it is now in phase 3 clinical trials in Africa, and licensure of this vaccine is expected by 2023.

“At present we are working on as many as 27 vaccinations, second to only the Serum Institute. In the non-COVID vaccines we are particularly focussed on our blockbuster product- our pneumococcal conjugate vaccine that we produce. We’re working on manufacturing a huge stock of that, and another very important vaccine we are working on is a new malaria vaccine. Other focus areas include the floodway antibody and the passive immunisation process. We are working on it in our labs in collaboration with the help of advanced backend hardware,” Dr. Jana informed.

He also maintained that to achieve their goal, they have multiple R&D facilities equipped with cutting-edge infrastructure and sufficient intelligent manpower. “Thanks to all of these, our routine work that includes working on vaccines be they therapeutic or any prophylactic or particular disease-preventing vaccine, which is essential in this post-pandemic world is carried on with no gaps,” he added.

Sanofi India’s Country Head also informed Financial Express.com that globally, their R&D pipeline includes 11 clinical-stage projects for vaccines to prevent diseases like Meningitis, Respiratory Syncytial Virus (RSV), Covid-19, and Rabies.

“Almost all prior long-term commitments related to vaccine supplies were achieved during the pandemic phase as well as during the maximum output of COVID-19 vaccine supplies.  BE vaccine output in FY20, FY21 and FY22 were similar in nature. In fact significantly higher quantity of two newer vaccines, Typhoid Conjugate Vaccine and Japanese Encephalitis Inactivated Virus Vaccine, were achieved in FY21 and FY22,” Dr. Vikram Paradkar told Financial Express.com.

Dr. Paradhar also informed that Biological E produces eight WHO prequalified vaccines that are supplied around the globe. 

“Multiple vaccines are in our pipeline that will reach commercialization status in next 3 years, with at least one new vaccine reaching market every year.  These include very important vaccines such as Pneumococcal Conjugate Vaccine, Inactivated Polio Virus Vaccine, Hexavalent Vaccine, Hepatits A vaccine, etc,” he said.

Supply of vaccines that are already commercialized (WHO-prequalified): Dr. Paradhar informed that BioE met the supply commitments in CY20, and 21 for almost all the vaccines and in several cases BioE supplied significantly higher doses in CY20 and CY21 as compared to CY19. These include vaccines such as Japanese Encephalitis inactivated virus vaccine, the Measles-Rubella vaccine, Td vaccine, etc.

Development of vaccines in R&D pipeline: Dr. Paradhar also said that significant progress was achieved with respect to multiple vaccines that are in our R&D pipeline and key milestones were achieved e.g. completion of clinical development of HepA vaccine, Completion of Phase III studies of PCV, etc. during the pandemic timeframe.

COVID-19 v/s Other incurable ailments

Almost all the major pharmaceutical and biotech companies around the world are working on finding ways to beat COVID-19 everyday. The global efforts towards manufacturing COVID-19 vaccines, drugs and other anti-COVID medical necessity is quite remarkable but the question arises: Is similar global effort towards other deadly and incurable non-covid diseases possible?

Biological E’s Executive Vice President (Manufacturing), Dr. Paradkar affirmed and said that the unprecedented collaborations established during COVID-19 pandemic will provide the blueprint for current incurable ailments either through vaccines or therapies.

“BE’s strategic manufacturing plan and high throughput/high efficiency operations enabled us to achieve significant additional vaccine output with essentially the same infrastructure and resources.  This gives us confidence that we can deliver similar response/results during next pandemic (God forbid!),” he added.

It is notworthy that through a collective approach, vaccine companies around the world developed and made available COVID-19 vaccines in a relatively short period. In order to achieve similar output in other diseases, close collaboration between regulators, industry, and clinical researchers is extremely important, industry experts told Financial Express.com.

“60 percent material comes from the United Stated alone, and maybe 10-20 percent come from European countries. So, due to the collaboration with the all state and the application of the AI and ML, we have found a suitable vaccine for the pandemic. Such joint collaboration has to be developed among scientists, the manufacturer, and laboratories within the same country and also outside the country. With the availability of AI and ML, smart data genetic and genomic data, institutes like MIT, and Oxford are collaborating. If this is done for every vaccine, every therapy, then it will be a win-win situation for all of us,” Dr. Jana told Financial Express.com.

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