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Covid-19 Vaccine Rollout
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Cold Chain in Vaccine Rollout: from COVID-19 Pandemic Perspective

It had been a year since the Novel Corona Virus (COVID-19) outbreak happened. Scientists had continuously strived to invent a vaccine, and finally, many pharmaceutical companies are coming up with their interventions. With the few of the clinical trials coming to a climax, the Pharma companies and Governments are pondering on the distribution of vaccines to billions of people and their supply chain management which poses as one of the major challenges.

From the time of manufacture till distribution, vaccines must be continuously stored in a limited temperature range, according to the type of vaccine. Different vaccines have different storage conditions like ambient, freeze-sensitive or frozen. Since vaccines are parenteral, optimal temperature and storage are to be taken care of to prevent any leakage and decrease in the efficacy of the vaccine. In order to tackle this challenge, WHO has recommended certain ‘cold chain’ principles to manage the vaccine roll out?

 

A temperature-controlled supply chain to maintain the quality of the product, in the desired low-temperature, is referred to as a Cold chain. A cold chain is said to be uninterrupted when there is controlled production, storage and distribution in the desired temperature using appropriate equipment and logistics. The cold chain is sometimes referred to as a vaccine supply chain or the immunization supply chain. There are a set of guidelines designed to keep the vaccine in WHO recommended temperature from the point of supply to the point of administration.

To maintain a reliable vaccine cold chain at the peripheral level, we have to

  • Store vaccines and diluents within the required temperature range at all sites
  • Pack and transport vaccines to and from outreach sites according to recommended procedures
  • Keep vaccines and diluents within recommended cold chain conditions during immunization sessions.

 

Cold chain logistics also referred to as chill chain logistics refers to the transport of temperature-controlled products like bio-pharmaceuticals, foods etc.

 

Requirements for Vaccine:

The cold chain has three key components: equipment for transport and storage, technical expertise, and effective procedures for management. In order to ensure secure vaccine transport and storage, all three components must be combined.

Proper cold chain management depends on proper temperature monitoring. Minor temperature excursion events (when the vaccine gets stored in temperature range outside the manufacturers’ recommendations), can impact the vaccines’ potency. Thermometers and data loggers should be used to monitor the transit temperature, and thermometers should be used for monitoring temperatures in the storage locations at sites of vaccinations, which must be continuously monitored.

 

Biologicals are sensitive to Heat, Light and Freezing.

 

The heat and freezing sensitive vaccines are categorized from Group A, which is more sensitive to heat and freezing to Group F, which are less sensitive to heat and freezing. Analyzing many observational studies, WHO has recommended +2 to +8°C as an optimal temperature for the vaccines which can be stored in normal refrigerators.

Freeze-sensitive vaccines produce adjuvants of aluminum which, when subjected to freezing temperatures, irreversibly lose potency. Freeze-sensitive vaccines require storage at 2 to 8°C and can lose potency even without visible signs that freezing has occurred when exposed to sub-zero temperatures.

Vaccines lose efficacy upon light exposure. To prevent the loss of vaccine efficacy, dark vials are used.

 

Equipment which are required for Cold Chain:

 

Different types of equipment are listed under the national cold chain system for transporting of the vaccines and storage of the vaccine. In the national cold chain system, we have three levels of hierarchy, i.e. Primary, Intermediate and Peripheral level. WHO has specified specific prequalification standards to ensure efficient performance of cold chain equipment?

 

Standard equipment for Cold Chain.

 

Refrigerators:

 

The most reliable power supply should be chosen for the refrigerator, i.e. either electrical, solar or gasoline. The storage capacity should fit for vaccine and water pack storage.

 

Cold boxes:

 

During transportation, cold box is used as an insulated container which can be lined with water packs for storage of vaccines and diluents in required temperature.

 

Vaccine carriers:

 

Vaccine carriers are easier to carry as they are smaller in size compared to other equipment. Current prequalified vaccine carriers have a cold life with frozen ice packs between 18 to 50 hours at +43 °C and a cool life with cool water packs.

 

For both cold boxes and vaccine carriers, the ice packs need to be conditioned before packing. Conditioning of ice packs involves completely frozen icepacks to be left at room temperature for a short time (around 30 minutes). This conditioning prevents the vaccines from getting frozen inside the cold box or vaccine carriers.

 

Water packs:

 

Water packs are used to line the interior of the cold box/ vaccine carrier. These are flat, leak-proof plastic containers that can be filled with tap water.

 

Foam pads:

 

It is a soft sponge which fits on top of the water packs inside a vaccine carrier.

 

Conclusion:

 

India being highly denser population where cold chain involves lots of inventory management, traceable trackers and appropriate storage since biologics are sensitive to minor changes of heat, light and cold. Planning and organization can help us in making the cold chain supply in rolling out the vaccine effectively.

India, being the second most affected country with COVID-19, Government of India is clearing the ground for vaccine rollout and mass immunization, as CDSCO is approving the vaccine use in India. It is pushing its pre-existing cold chain suppliers to augment the requirements based on various players in the market. While Pfizer vaccine recommends a storage temperature of -70°C±10°C during transit and 2-8°C for storage up to five days, Moderna wants the vaccine to be frozen at -20°C during transit. With such restrictions, India’s cold chain logistics industry is gearing up to meet the requirement, but the task looks difficult (though not unachievable being optimistic). Having the vaccine stored and transported at this temperature requires major planning and involves expenditure. The challenge is to get the vaccine transported and distributed to the vulnerable population in remote parts of the country and also to maintain the capability to transport such bulk load without affecting the vaccine. The Indian company vaccines are better when compared for the storage conditions where the manufacturers like Serum and Bharath Biotech have said that their vaccines can be stored in regular refrigerators at 2-8°C. Therefore, in this case the investment will be smaller comparatively.

With the COVID-19 pandemic slump hitting out at all people, together with lockdowns announced in the country, there were significant impacts on all the businesses big and small. But with this phase, the cold chain industry is going to have significant growth and is sure to get revamped for good, and we hope so.

 

 

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Effect of Lockdown on Clinical Trials

The pandemic lockdown and quarantine has slowed down or in some cases paused most of our everyday lives. With daily routines affected, there is a butterfly the effect that ended up affecting most professions in some or the other way- including the clinical research industry.

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With the whole world focusing on COVID19 research, much of non-COVID19 related ongoing and upcoming projects have taken a backseat – especially, in-person operations. This doesn’t necessarily mean a complete halt in the research process, regulatory bodies like USFDA have issued guidelines on conduct of clinical trials during COVID-19 pandemic. Although these guidelines are designed to tackle current pandemic, these changes are bound to have short term implications that could potentially shift the way in which the industry functions in the long term.

Effects on research operations/procedures/ trial progress:

Trial sites that have been transformed or dedicated for COVID-19 treatment may not be capable of recruiting or conducting future trials. At the same time, the recruitment and conduct of ongoing trials have taken a significant hit with most of the investigators and healthcare personnel catering to COVID patients and pandemic. Especially in our country where the patient to doctor ratio is high enough in general circumstances, doctors involved in trials might have to shift their focus on providing COVID related services and their availability at trial site might be irregular.

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Transport restrictions during lockdown have disrupted supply chain of investigational products since the investigational products cannot reach the trial site, products under manufacture are on hold due to non-functional or dysfunctional manufacturing units and unavailable labor. Moreover, global trials might face delays in product delivery since most countries have closed their borders for international travel, import and export.

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In the early stages of the pandemic, the question was of taking critical decisions on withholding or postponing trials in the recruitment or pre-recruitment stage for trial sponsors. A significant impact of lockdown can be observed on global trials with respect to difference in trial conduct due to varied pandemic related restrictions like some countries are able to conduct trials as per schedule, while others are not able to.

So far, the regulatory bodies including CDSCO have issued guidelines with respect to the challenges in trial conduct for continuity and progress of ongoing trials. These guidelines mandate sponsors and CROs to take necessary actions such as protocol deviations while prioritizing patient safety and data integrity.

However, several ethics committees or review boards might be temporarily non-operational due to lockdown restrictions which could pose as a considerable hurdle for obtaining regulatory clearances and approving the mandated amendments for ongoing or upcoming trials. This is a major challenge since a protocol deviation would require the sponsor/CRO, regulatory authorities and ethics committees to coordinate. As companies learn to adapt and consider implementing new strategies to keep clinical trials on track, in many cases the only option is to temporarily pause or delay development programs.

Effects on trial participants:

Trials with the following population would face most of the challenges because of the pandemic: –

  • enrolled populations, including the elderly, the immunocompromised, and patients with pulmonary conditions (e.g., COPD)
  • Have primary or secondary endpoints that require in-person visits or hospital infrastructure and equipment (e.g., CT and PET scans) for assessment.
  • Trials that require in-person screening.
  • Involve indications with minor safety or quality of life implications for patients (e.g., “lifestyle drugs”) and indications where a patient’s environment has a significant impact on therapeutic success (e.g., psychiatric and neurological indications)
  • Are currently in the patient recruitment stage or are in Phase 1 with healthy participants
  • An infection in the participants may affect the outcomes of the study and in some cases, some participants may need to be withdrawn from the trial.

 

These consequences could be especially devastating for trials in rare diseases, where available patient population is very small.

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Effect on companies /research organizations:

Delays in projected launch timelines could occur as a result of delayed clinicaltrials. This may in turn lead to shorter time period of patent validity and lower near-term revenue forecasts. Changes in launch timelines have the potential to alter competitive scenarios in many therapeutic areas and other facets of the industry, where in the opportunities are up for grabs for whoever adapts and responds to pandemic related changes exceptionally.

Companies, especially small scale, have to adapt to renewed guidelines and switch to operating remotely, or re-evaluate efficiency of current mode of operations, while following the prescribed regulatory measures. This in turn could be a significant problem for those who weren’t adept with appropriate resources in order to make necessary transitions in their mode of operations. The impending economic crisis would only weigh into this un-resourcefulness. This is particularly challenging for countries (like in Europe) where legalities such as General Data Protection Regulation (GDPR) could obstruct the remote functioning of trials.

Pricing negotiations also could be impacted by the pandemic, especially for some non-COVID-19 therapies (e.g., the third or later drug to market in a class) which are perceived to be of low unmet need. New recruitments into companies be on hold due to postponed graduations and current workforce might take a hit because of economical setbacks that could ultimately effect company productivity.

Conclusion 

Like any other industry Clinical research industry should come up with some solutions to fix the problems associated with COVID-19 pandemic. The obvious solutions recommended are decentralizing and partnering. For example, home visits, shipping investigational products to participant’s residence, sample collection from home or nearby pharmacies can help performing a clinical trial even in lockdown. Instead of halting, it is time to resume the clinical operations but close monitoring of situations and safety of research staff should remain a priority.

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Current Trends in Pharmacovigilance

Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection assessment, monitoring and prevention of adverse effects with pharmaceutical products. The latest news is the outbreak of coronavirus which has been declared as the global emergency, by WHO, as it could spread to countries with fragile health systems. The scientists from china isolated the virus but didn’t share the sample, but the virus genetic sequence has been made available to the international researchers. However, researchers from Melbourne has isolated the virus from the first diagnosed person with infection in Australia. Now, this sample has been shared to the research labs around the world (recommended by WHO) to develop the accurate diagnostic tests and vaccines. This infection can be treated in two ways: antivirals and antibody vaccines but the most reliable method (in aspect of time and efficacy) vaccines are more preferable. Many companies are ready and agreed to perform the trails and produce the medicines to forbid the virus becoming an endemic infection.

pharmacoviglance

And according to the latest news as on 31 January 2020, a doctor from Tamil Nadu state claims that his knowledge in siddha and Ayurvedic medicines can help in curing the corona virus fever with the herbal extract which is used to treat dengue, multi-organ fever and acute liver fever.” “We want to tell the World Health Organization (WHO) and the Chinese government that our medicine is very effective in treating multi-organ failure in corona fever condition,” he said.

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New rules for clinical trials and their effect:

India’s Ministry of Health and Family Welfare (MoHFW) has published the final version of New Drugs and Clinical Trials Rules, 2019. The new regulations cover provision for promoting clinical research as well as complex topics such as orphan drug, post-trial access, and pre and post-submission meeting. The new rules appear comprehensive, well-balanced, and likely to improve the ethical and quality standards of clinical trials in India, which will further benefit patients and industry.

These rules will help, to provide patients with earlier access to drugs and also speed up the trial process and encourage local drug development. Provision for accelerated product approval under some conditions, especially pre and post-submission meetings with authorities, may add increased predictability and confidence in the system.

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Real World Evidence from Retrospective Study: A New Approach

Choosing the best accessible therapeutic and preventive measures to avoid suffering from diseases leading to disability and death is an important goal for all health care professionals. To accomplish this objective, the health care community seeks information on data to support critical decision making while choosing interventions during clinical practice.  A retrospective clinical study looks backward in time, usually using the medical records and interviews with patients who are already known to have a medical condition. The study looks backward and examines exposures to suspected risk or protection factors in relation to an outcome which is established at the beginning of the study. A “Retrospective study” is played out a posteriori, utilizing data on occasions that have occurred previously. In most cases, some or most of the information has just been assembled and put away in the library. In a retrospective study, different patient populations can be compared to one or several outcomes.

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Currently, Real-world data and real-world evidence are helping in health care major decision making. Retrospective studies help in collecting the information from different sources of health records which can be used for evaluating new approaches to prevention and treatment. They can be used to help formulate the hypothesis, focus the questions and identify any major issues before a prospective study begins. These studies are relatively inexpensive and faster to conduct than other studies. A retrospective study is often used in medicine, but they are now used by real-world study and real-world experience also. Abiogenesis Clinpharm is an emerging Clinical research organization in Hyderabad (CRO) in Hyderabad which provides client-specific services in the area of clinical development of drugs. Retrospective Studies conducted at Abiogenesis Clinpharm are economical, quicker to analyze and finish than prospective randomized controlled clinical trials.

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Benefits of Medical Monitoring for Clinical Trials

The benefits of doing Medical Monitoring for Clinical Trials research include experiential learning that has the potential lead to practice change and improved patient outcomes that are evidence-based. Clinical trials are logical research contemplates where new medications, treatment strategies, and indicative systems are connected to getting human patients all together decide their well-being and viability. Clinical preliminaries are basic to guarantee that medication treatment is ok for the mass market. The expense of directing a clinical preliminary for medication is rising like mercury on a sweltering summer evening.  A clinical trial starts with an idea. Researchers in a lab notice something they haven’t anticipated or think of something that could enhance the results they get that can also be applied elsewhere. Abiogenesis team who are highly skilled staff and well-versed in implementing Protocol writing, Medical monitoring, and managing clinical study reports.
 
clinical research
During Monitoring Visits, which are occasionally happening visits from the support Clinical Research Associate (CRA), therapeutic screens are in charge of confirming the rights and prosperity of human subjects are ensured and the preliminary information is consistency with the endorsed convention, Great Clinical Practice (GCP) and other administrative prerequisites. This process Our Team Abiogenesis Has Experience and Expertise in Medical Monitoring for Clinical Trials of Drugs, Vaccines, Medical Devices and Herbal Products. We contain individuals with the correct mentality, adaptability, dependability, and responsibility for magnificence. Our ability originates from the experience of experts having qualifications of effectively leading national and global clinical preliminaries in every one of the periods of clinical improvement crosswise over Different Therapeutic Areas.
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Clinical Research Services for Biologics and Pharmaceutical Companies

Abiogensis Clinpharm is a Specialised Clinical Research Organization (CRO) offering end-to-end clinical development for drugs, Bio-similars, Vaccines and devices across many therapeutic areasOur comprehensive clinical research services provide successful clinical trials with very cost effective way.

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Our team has operational experience in conducting many trials and also well versed with many operational challenges. The team works in coordinated manner to meet timelines, budget, and delivery of quality data. 

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What are Clinical Trials?

Clinical trials  also called as clinical research designed to evaluate safety and efficacy of promising therapeutic products having potential to reach market. Abiogenesis Clinpharm helps in conducting trials with ideal design considered optimum for a therapeutic product. As a best clinical research organisation in India, the team is well versed with appropriate recruitment strategies, quality procedures and essential data handling. We provide services in regulatory, medical writing and medical monitoring for clinical trials along with statistical analysis, clinical data management and post-marketing surveillance studies to the clients.Concerns on meeting sponsor timelines are exclusively addressed to get timely recruitment and putting operational methods in place which makes conduct of the trial easier.  Abiogenesis Clinpharm Private Limited would be the best partner for pharmaceutical, Nutraceutical and Medical Device Companies worldwide to carry the development of their promising and potential therapeutic products.
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Phases of Clinical Trials

Phase I studies: New investigational product tested in smaller groups of healthy volunteers (SAD: Single Ascending Dose or MAD: Multiple Ascending Dose).

Phase II studies: Product is investigated in smaller number of patients to explore ideal dose with better efficacy & safety.

Phase III studies: Investigational product is tested in large number of patients from multiple centers to confirm the suitable dose for marketing approval.

Phase IV studies: Following a product approval, post-marketing trials are conducted to monitor safety and efficacy for long-term risks and benefits including detection of rare or very rare side effects.