Nepal: Waiting for COVID-19 Vaccine

Everyone is asking the question, when will the vaccine come to Nepal? We tried to find the answer from Dr. Suresh Tiwari, a public health expert, and Dr. Jageshwor Gautam, Spokesperson, Ministry of Health and Population, but unfortunately, they were not available for comment. We did talk to Dr. Prakash Ghimire, Professor of Microbiology, Tribhuvan University, who shed light on various issues to do with vaccines.

With the approval of several COVID-19 vaccines, the world’s focus, now, has shifted to procuring safe and effective vaccines for their citizens. Countries like Russia, China, UAE, Saudi Arabia, UK, and US have started vaccinating their citizens, and countries that need to import vaccines are rushing to make deals with multiple companies—many of them booking the vaccines by making advance payment even before the vaccines are authorized.

As every country wants to secure their share of vaccines, not only is there a need to act fast, but also a need for proactive planning in terms of supply-chain logistics, administration-site selection, and service delivery, which are critical for rapid mass immunization when the vaccine arrives. While governments around the world are at different levels of planning on who and how the first round of vaccinations will be delivered, Nepal’s government is yet to disclose how and when the COVID-19 vaccines will become available, and if negotiations are underway with any vaccine companies.

So far, Nepal has sent diplomatic notes to seven countries whose vaccines have either received emergency approval or are close to third phase trials, seeking for early availability of vaccines when they are approved for use. The government has also passed an ordinance to facilitate the use of emergency medicines and vaccines for COVID-19 that have been tested and approved in other countries.

“But, most of the vaccine makers are private companies,” says Dr. Suresh Tiwari, a public health expert, talking to AP1 HD’s The Bravo Delta Show. He says the countries that we have written to are not obliged to send us vaccines just because we have written to them, as their first priority will be their own citizens. “So, the government needs to act fast, make demand for the required number of vaccines to manufacturing companies, and send them a purchase order, along with the payment, to secure the deal without any delay.”

“If we can book the vaccines through G2G model, we should just do it, but since private companies are involved, we should start negotiating with the manufacturers, too. For this, the government can involve private sectors and encourage them to use all their networking capabilities to negotiate with the manufacturers,” he added.

In another interview with AP1 HD TV, Health Minister Bhanu Bhakta Dhakal said that we could book the vaccines either through G2G model, by requesting countries to make the vaccines available to us, directly negotiating with the vaccine manufacturers, or involving the private sectors to bring vaccines to Nepal.

According to him, the government has formed a committee, representing secretaries of finance, home and foreign affairs ministries, to facilitate early import of the vaccines. There are also several technical teams working with the committee. They are working mainly based on four criteria: availability of vaccines, prioritizing vaccines that are suitable to our infrastructure, cost, and the quantity of vaccines.

According to the Health Ministry, 72 percent of the country’s population will be vaccinated. The remaining 28 percent, who are children under 14, will be excluded until the vaccines are considered safe for them.

Of the targeted population, Minister Dhakal said that the government will purchase vaccines for 52 percent of the population, while the vaccines pledged by COVAX will be used to cover the rest 20 percent. The government, however, would not wait for COVAX to start the immunization program, he added.

He also said the COVID-19 vaccines will be administered free of cost, as national immunization is one of Nepal’s most successful public health interventions and falls under its high priority program. The government has been providing seven other vaccines, including BCG, DPT, oral polio vaccine, and measles, for free in the country. The vaccination campaigns were carried out even during the insurgency and in the aftermath of April 2015 earthquake, he informed.

Regarding the country’s capacity for cold-chain vaccine distribution, the minister said that Nepal might already have a mechanism to handle vaccines maintained at 2-8 degree Celsius. There are 16,000 vaccination centers across the country currently being used for other immunization programs. If we were to bring vaccines that could be stored at normal refrigerator temperature, he said there would be no problem.

The government’s first priority would be vaccines that can be stored at 2-8 degree Celsius, followed by vaccines stored at minus 20 degree Celsius and minus 70 degree Celsius, respectively, he said.“Vaccines requiring sub-freezing temperatures will be our last priority, as we need time to build the infrastructure.” In a situation where only such vaccines are available, he said, the vaccines would be prioritized for doctors, nurses, health workers, and frontliners.

According to him, the estimated budget for the vaccines is around Rs. 49 billion, and the government will prioritize 20 percent of the vaccine in the first phase.

While vaccines are being rolled out in many countries, many people are also worried that the fast-tracked vaccines might not be effective, or could carry long-term side effects. Medicos Next…caught up with Dr. Prakash Ghimire, (Professor of Microbiology, TU) with expertise in vaccinology and research to talk about the different criteria to consider before buying a vaccine, its efficacy, long-term side effects, and the registration of a vaccine. Here is what he has to say.

What are the criteria that we need to consider while buying a vaccine?

  • Safety
  • Immunogenicity
  • Efficacy
  • No to only minor adverse events following immunization
  • Operationally feasible for storage (2-8oC) and transfer to immunization centers with vaccine vial monitors, operationally suitable for individual immunizations (no more than 10 vaccine doses in a vial for single day/sitting use)

There are different types of COVID-19 vaccines like mRNA, adenovirus, protein, and inactivated cold virus that have received emergency approval for use in the US, UK, Canada, and UAE. How do these vaccines work?

 

Many conventional vaccines use whole viruses to trigger an immune response. There are two main approaches. Live attenuated vaccines use a weakened form of the virus that can still replicate without causing illness. Inactivated vaccines use viruses whose genetic material has been destroyed so they cannot replicate, but can still trigger an immune response. Both types use well-established technology and pathways for regulatory approval, but live attenuated ones may risk causing disease in people with weak immune systems and often require careful cold storage, making their use more challenging in low-resource countries. Inactivated virus vaccines can be given to people with compromised immune systems but might also need cold storage.

Subunit vaccines use pieces of the pathogen—often fragments of protein—to trigger an immune response. Doing so minimizes the risk of side effects, but it also means the immune response may be weaker. This is why they often require adjuvants to help boost the immune response.

Nucleic acid vaccines use genetic material—either RNA or DNA—to provide cells with the instructions to make the antigen. In the case of COVID-19, this is usually the viral spike protein. Once this genetic material gets into human cells, it uses our cells’ protein factories to make the antigen that will trigger an immune response. The advantages of such vaccines are that they are easy to make, and cheap. Since the antigen is produced inside our own cells and in large quantities, the immune reaction should be strong. A downside, however, is that so far, no DNA or RNA vaccines have been licensed for human use, which may cause more hurdles with regulatory approval. In addition, RNA vaccines need to be kept at ultra-cold temperatures, -70 OC or lower, which could prove challenging for countries that don’t have specialized cold storage equipment, particularly low- and middle-income countries.

Viral vector vaccines also work by giving cells genetic instructions to produce antigens. But, they differ from nucleic acid vaccines in that they use a harmless virus, different from the one the vaccine is targeting, to deliver these instructions into the cell. One type of virus that has often been used as a vector is adenovirus, which causes the common cold. As with nucleic acid vaccines, our own cellular machinery is hijacked to produce the antigen from those instructions in order to trigger an immune response. Viral vector vaccines can mimic natural viral infection and should therefore trigger a strong immune response. However, since there is a chance that many people may have already been exposed to the viruses being used as vectors, some may be immune to it, making the vaccine less effective.

Is the efficacy of these vaccines same across all age groups? Do they have any long-term side effects? How safe are they for pregnant women and growing children?

No, it may be different in different population groups; that is why clinical trials are done in broader groups of population to understand its efficacy in different population groups (age groups, risk groups, ethnic groups, race, etc.).

Till date, the studies of almost nine months have limited information on safety, immunogenicity, and efficacy. Available information from the recent clinical trials have shown good safety, immunogenicity, and efficacies in different population groups (18-65). Its safety and efficacy in specifically vulnerable groups of population, including pregnant and breast feeding women and children, are limited, so these group of population are advised to consult with their treating doctors before taking the vaccines.

What is the role of Nepal Health Research Council (NPHL) in registering a vaccine?

Registration of any vaccines and drugs in the country is the role of National Regulatory Authority, Department of Drug Administration, as mandated by the Drug Act 2035. Nepal Health Research Council has been mandated by the NHRC Act of parliament, in 1991, for conducting and regulating research related to human subjects, which include ethical approval of clinical trial of vaccines and regulating ethical conduct of the research during implementation.

What is NHRC’s plan in evaluating the long-term side effects of COVID-19 vaccines?

NHRC as mandated by the NHRC Act, 1991, will regulate ethical conduct of the research, including clinical trial of COVID-19 vaccine, when any get approval, through its process of review and approval in line with international guidelines (Nuremberg code, CIOMS guideline, FERCAP guideline)

What is COVAX allocation? Will every country get the pledged 20 percent vaccines at the same time?

COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator. The ACT Accelerator is a ground-breaking global collaboration to accelerate development, production, and equitable access to COVID-19 tests, treatments, and vaccines. COVAX is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and WHO. Its aim is to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.

What is the prequalification process for COVID-19 vaccines?

There is no WHO prequalified vaccine against COVID-19, till date. For emergency use, WHO has introduced WHO Emergency Use Listing Procedure (EUL), which is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics, and in vitro diagnostics, with the ultimate aim of expediting availability of these products to people affected by a public health emergency. This will assist interested UN procurement agencies and member states in determining the acceptability of using specific products based on an essential set of available quality, safety, and efficacy and performance data.

WHO prequalification ensures vaccines used in immunization programs are safe and effective. It is a comprehensive assessment that takes place through a standardized procedure aimed at determining whether the product meets requirements for safety and efficacy in immunization programs. The full prequalification assessment process includes the following components:

o Review of production process and quality control procedures.

o Laboratory testing.

o WHO site audit to manufacturing facilities with the responsible National Regulatory Authority.

Once a vaccine is prequalified and introduced to the market, WHO ensures it continues to meet standards through:

o Reassessments at regular intervals.

o Targeted testing of lots supplied through UN agencies.

o Investigating any complaints from the field and reports of adverse events following immunization (AEFI).

 

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