Effectiveness of AstraZeneca’s COVID–19 vaccine increases with a 3 months gap before the second dose: AstraZeneca and Oxford have claimed that their vaccine was more effective with a 3 – 3-month gap before the second dose. This was revealed in a peer–reviewed study in a medical journal called The Lancet on 19 February 2021.
Initially, the second dose was administered six weeks after the first dose, and the efficacy was found to 55.1 %. However, when the second dose of the vaccine was given 3 months after the initial dose, the efficacy rose to 81.3 %. As per the researchers involved in this study, this extended dosage regimen can benefit the patients. They believe that this regimen will help sort out the limited supply of the vaccine. Apart from this, the researchers also claimed that this would allow for rapid immunization of a large population in the countries.
This study also validated the previous findings of the company’s vaccine. The previous finding showed that the vaccine has an efficacy of 76 % against symptomatic patients for up to 3 months after the initial dose. This was revealed at the beginning of February 2021. Despite these findings, the scientists remain unsure of the exact duration for which the protection of a single dose of the vaccine can last. This is attributed to the fact that the trials can only be limited to 3 months period, and hence the scientists recommend a second dose.
About the study:
This recent study was done to understand the effect of the different intervals on the protection offered after the second dose is given. The risk of infection between the two doses’ administration was also analyzed in this study. These changes could be due to the first dose’s lower effectiveness; or the rapid declining effect while waiting for the second dose. The data collected from over 17,178 participants in the United Kingdom, Brazil, and South Africa were used for this purpose.
The World Health Organization has also approved AstraZeneca’s COVID–19 vaccine for emergency use in the third week of February 2021. This, in turn, has paved the way for the distribution of this vaccine to developing countries through the COVAX program.
Lupin and Aurobindo Pharma initiates nationwide recall of certain medications in the US market:
The latest enforcement report of the USFDA has led to the recall of certain medications by two major pharma companies. The companies involved are Lupin and Aurobindo Pharma. These drug firms are recalling some of their products from the American market.
Baltimore – based unit of Lupin Pharmaceuticals Inc. has been actively recalling an antiviral medication. This medication is called Oseltamivir Phosphate for Oral suspension, and over 46,479 bottles are being recalled.
This product was manufactured at the manufacturing plant of the company in Aurangabad, Maharashtra. The nationwide recall was initiated on 21 January 2021 due to “failed impurities/degradation specifications.” This type of recall is categorized as a class III recall by the USFDA. Such a situation occurs when the use or exposure to the violative products does not cause any adverse effect.
The Hyderabad – based drug maker, Aurobindo Pharma, is also undertaking similar measures to recall Acetaminophen injection.
Acetaminophen injection is used to treat moderate pain and fever. Over 3,094 cartons are being recalled, and this is initiated by the East Windsor-based unit of the company. The lots that are being recalled have been manufactured in India, and this action began on 30 December 2020. AuroMedics Pharma has announced that this recall is due to the “failed discoloration and pH specifications” of the product.
As per USFDA, this recall is classified as a Class II recall. This type of recall is put into effect when the use or exposure to the violative product causes temporary or medically reversible side effects.
This recall is also initiated when the products involved have slim chances of causing severe adverse effects.
Abbreviation: 1. The United States Food and Drug Administration
Lupin’s Posaconazole Delayed-release tablets launched into the market after receiving approval from the USFDA :
On 17 February 2021, Lupin Limited announced the launch of Posaconazole delayed–release tablets in the United States. This tablet is marketed at the dose of 100 mg. The approval for the ANDA product from the USFDA was secured by the pharma company’s alliance partner. This alliance partner is a part of the Tiefenbacher Group and is called AET Pharma US Inc.
This delayed–release tablet is the generic equivalent of Noxafil Delayed-release tablets, 100 mg. The latter is manufactured by Merck Sharp & Dohme Corp.
Posaconazole Delayed-release tablets
A major indication of Posaconazole is the prophylaxis of invasive Aspergillus and Candida infections in immunocompromised patients. These patients are at a high risk of developing infections. They include hematopoietic stem cell transplant ( HSCT ) recipients with graft – versus – host disease ( GVHD ). Apart from these patients, others who need this drug are those with hematological malignancies together with prolonged neutropenia as a result of chemotherapy.
As per IQVIA MAT, Posaconazole delayed-release tablets had an annual estimated sales of over USD 186 million in the US. This sales value was obtained based on the data obtained till December 2020.
About Lupin Pharma
Lupin Limited is one of the largest generic pharmaceutical companies by revenue globally. It is an Indian multinational pharmaceutical company based in Mumbai. The company started its operation in 1968 and among the top 5 pharma players in India today. The company’s key therapeutic segments include Diabetology, Cardiovascular treatments, Pediatrics, Anti-infectives, Respiratory, and Anti-tuberculosis.
The BioNTech/Pfizer COVID – 19 vaccines can be stored at – 25 to – 15 degrees Celsius for up to two weeks:
On 19 February 2021, Pfizer announced that its COVID -19 vaccine could withstand warmer temperatures in pharmaceutical freezers and refrigerators. This jab can now be stored for up to 2 weeks at – 25 to – 15 degrees Celsius ( – 13 to 5 degrees Fahrenheit ). The company has contacted the USFDA to seek this storage temperature approval.
Pharma News – 20 February: Pfizer’s COVID–19 vaccine storage requires complex cold–chain logistics as per the existing guidelines. It can only be stored at – 80 to – 60 degrees Celsius until five days before use. This process requires special ultra–cold containers for shipping and dry ice for storage. Owing to these reasons, the management of this vaccine becomes difficult. If approved, the company claims that the new storage condition would greatly improve this situation regarding the vaccine supply.
About BioNTech/Pfizer COVID –19 vaccines
Pfizer’s mRNA technology-based vaccine, in collaboration with BioNTech, was the first COVID – 19 vaccines approved in the West in late 2020. Following this, Moderna’s vaccine was approved. This US–based pharma company’s vaccine was developed using similar technology but differed in storage conditions. It could be stored at – 20 degrees Celsius for around 6 months. Moderna’ vaccine can also be stored at normal fridge temperature for up to 30 days.
Apart from these shots, the vaccine developed by AstraZeneca / Oxford University was also approved. This vaccine was developed as per the traditional norms and can be stored and shipped at standard conditions.
The CEO of BioNTech stated that both the drug majors are currently working on new formulations of this vaccine. This was being done to overcome the difficulty in storing and shipping the vaccine. The firms have also begun to conduct trials on over 4000 healthy pregnant women from around nine countries. The countries participating in this trial are the United States, Canada, Argentina, Brazil, Chile, Mozambique, South Africa, Britain, and Spain.
At the beginning of the third week of February 2021, the United States volunteers were given the first dose of this vaccine.
Another study conducted on approximately 9000 medical staff at Sheba hospital near Tel Aviv revealed some results. These volunteers were administered the first dose of the vaccine (BioNTech/Pfizer COVID – 19 vaccines) and showed that this dose was 85 % effective against the infection. This efficacy was evident between two and four weeks after inoculation.
The terms’ vaccination’ and ‘vaccine’ are derived from Variolae vaccinae (Cow smallpox). These terms were given by Edward Jenner (who both developed the concept and created the first vaccine) to denote cowpox. In 1881, to honor Jenner, Louis Pasteur proposed that these terms should cover the inoculations of other types of disease-causing pathogens that were then being developed.
Chemically, a vaccine is any biological preparation that promotes an active acquired immune reaction to a pathogenic infection/disease in the human body.
What is a vaccine?
In simple words, a vaccine can be explained as an external agent that essentially contains a biological substance. This resembles the disease-causing pathogen. The biological agent used is a weakened/killed/fragmented/broken-down form of the infection-causing pathogen to ensure that the vaccine is not harmful. The vaccine’s antigenic property is based on the human body to recognize this fragment of the pathogen (surface proteins, toxins, chemicals, cell wall, etc.). Once encountered by the immune cells of the biological system, this external agent is considered a threat, and thus, the body works to cause its destruction. Several different types of immune cells take part in this reaction. Additionally, our body’s immune cells (memory B cells) tend to recognize any related microorganisms associated with the agent present in the vaccine. As a result, if the body encounters any threat in the future by any related organism, the infections are countered.
The use of the vaccine has been the healthcare industry’s highlights in the present times. These biologics can make the human body fight off infections independently and become important in treatment courses. The process of administration is referred to as vaccination. Since the discovery, widespread immunization of people against different infections has resulted in restriction and eradication of infections. Smallpox has been completely eradicated, while polio, tetanus, and measles have been greatly controlled. Depending upon the use, it can be used as a prophylactic (management of infection) or as a therapeutic entity to cure a disease that has already occurred. World Health Organization (WHO) has reported that licensed vaccines are presently available to the world for more than twenty different infections. Vaccines developed for other diseases include influenza, HPV, chickenpox, tuberculosis, mumps, and rubella.
Mechanism: How does it work?
The high degree of safety and efficacy over a large population helps fight off infections in a widespread manner.
The biological immune system has cells that act to destroy the external agent present in the vaccine and remember this agent’s strain and characteristics. The immune system recognizes vaccine agents as foreign, destroys them, and “remembers” them. When the body encounters a pathogenic version of an agent, it recognizes the protein coat on the virus previously present in the vaccine and thus is prepared to respond. Initially, the immunological cells try to neutralize the target agent before entering to infect cells, and further by recognizing and destroying infected cells before that agent can multiply to vast numbers.
With all the therapeutic success of these vaccines, some lacunae limit their effectiveness in eliciting the immune response. There have been reported cases of failure. This failure for protection might result from vaccine-related failures such as fault and ineffectiveness in attenuation, vaccination regimes, or administration or host-related failure. The host-related failure could be due to the host’s non-responsive immune system. Research has also suggested the influence of predisposing factors, including genetics, age, health, immunity, and nutrition. If a person receiving vaccination has some genetic anomaly, it could fail if the body fails to make the memory B cells to make antibodies. Factors including age and health status, signify a general perspective towards an individual’s immunity. Older people are found to have a weakened immune system and overall health status.
Additionally, there are cases when people develop the antibody to fight off the infection. However, the degree of protection (i.e., number of antibodies) is inadequate, or the immunity develops too slowly to elicit the required response. There may also be a possibility that the immune system fails to kill the pathogen completely, or there are possibilities of a different mutant strain of the pathogen. Thus, there are some minor inconsistencies, but an inadequate response may curb the infection. This will result in a lower mortality rate by that disease.
To manage vaccines’ efficiency for the older population, adjuvants are added. These adjuvants have an additional immune reaction, thereby boosting the immunity against the pathogen.
Factors under consideration
Conclusively, the performance of vaccines is influenced by multiple factors, including –
The strain of the pathogen
The specificity to a limited strain
Scheduling and booster doses
Idiosyncratic, unknown reactions
A novel breakthrough infection
Proper epidemiological study of the pathogen and virulence
Types of Vaccines
There are different types based on the type of agent used.
With recent research developments, there has been a novel understanding of using the pathogen’s genetic makeup to develop a vaccine. Different types are –
Live, attenuated vaccine – these contain a living, weakened version of the disease-causing pathogen. The weakened microbe cannot cause a flow blown infection. These are the closest to natural infections.
E.g., measles, mumps, the chickenpox vaccine.
Inactivated vaccines – these result from killing the disease-causing pathogen by chemical methods (radiation, heat, or chemicals). Since the pathogen is killed, there is no possibility of mutation of organisms into a disease-causing state. These are, therefore, very efficacious, safe, and stable.
E.g., influenza, polio, rabies, hepatitis A vaccine.
Subunit vaccine – consist of specific antigens of a pathogen that are most potent in activating a high degree of immune reaction. The subunit vaccine only contains the essential antigens and not the other molecules making up the microbe.
E.g., Immunization of Plague
Toxoid vaccine – toxins are harmful chemicals secreted by the pathogens. The vaccines of toxoid origin are used against an illness caused due to such endotoxins and exotoxins. Research has presented that toxins can be inactivated using formalin. The inactivated toxins are called ‘toxoids’ and are safe.
E.g., Crotalus atrox toxoid vaccine
Conjugate vaccines – polysaccharides (complex structures of the bacterial cell wall) can mimic the bacterial antigen and can be isolated to be used as a vaccine. The scientists try to make a conjugate vaccine for it. Such a product is called a conjugate vaccine.
E.g., Haemophilus influenzae type B vaccine.
DNA/RNA vaccines – vaccines consisting of genetic material as the antigen has been a recent development. This holds great promise for a majority of viral diseases. The development requires a high degree of precision such that it does not alter the host genome and show an unintended immune response.
E.g., mRNA vaccine for SARS-CoV-2.
Recombinant vector vaccines: A vector refers to the virus or the bacterium used as a carrier of any pathogen’s genetic material. These vaccines have recently developed that function on the same lines as the DNA/RNA vaccine. The antigenic genetic material is added to the recombinant plasmid vector and introduced to the vaccine’s immune system.
E.g., DPT vaccine
Vaccine development: How are they developed?
It takes about 12-15 to develop and distribute any vaccine to the public as per an estimate. However, as an exception to the COVID-19 pandemic, the development is rapid as a shunt pathway is used. The tests for safety and efficacy as a part of a clinical trial typically covers a period of 10 years. The COVID vaccine development has been modified, and safety and efficacy estimates have not been studied in great detail. However, they are quite accurately predicted. Upon authorization, drug regulatory scaling up off vaccine manufacturing begins. To develop a fully packaged product, weakened antigens and other excipients are added for stability and transport. The flow chart below gives an idea about the development and further distribution to the public.
Manufacturing, safety, and Quality Control
The manufacturing process is carried out in a GLP certified lab and following all the GMP rules. The labs for development and manufacturing units are usually biosafety level 3 and 4 (BSL 3 & 4). This ensures proper containment and reduces infection risk to the working class.
Post manufacture, vaccines are stored in controlled temperatures to maintain efficacy. Most are stable between 2-8⁰C. Some require temperatures of -20⁰C, while the recently developed vaccine for COVID-19 requires to be kept at a temperature of -70⁰C. Thus, special storage and transport units are simultaneously being developed. Inter-country transport involves using refrigerators and iceboxes.
To maintain and ensure that people being vaccinated are safe from infection, national regulatory bodies and WHO constantly monitor the population for possible side effects and idiosyncratic reactions. Thus, the post-marketing surveillance and pharmacovigilance (regular assessments and post-approval clinical studies); are of utmost importance. Additionally, research studies are carried out to determine how long it would remain protective and effective.
COVID vaccines are designed to improve the immune response of our bodies to the virus that causes COVID-19. This, in turn, helps to avoid contracting and developing the illness. Different types of vaccines work differently to ensure this; however, COVID vaccines can do this task by one common mechanism. The vaccines do their function by producing a supply of “memory” T-lymphocytes and B-lymphocytes that will remember how to fight the COVID virus if the body is exposed to it in the future. Let us know the details of the COVID Vaccination Program in India.
COVID vaccine: Is it safe?
Sometimes after vaccination, symptoms such as fever are manifested. These symptoms are normal and indicate that the body is building immunity. Although there are no serious and life-threatening side effects with this vaccine, the Centers for Disease Control and Prevention (CDC) has advised patients to remain cautious. It has revealed that people with allergies to certain food, insects, and latex may be allergic to the COVID vaccine. This is particularly seen in the case of the Pfizer/BioNTech vaccine. Hence, patients prone to allergies are advised not to receive this vaccine.
COVID Vaccination Program rollout in India
On 3rd January 2021, the Indian drug regulators gave the go-ahead for two COVID vaccines. These vaccines will be used for the mass immunization programs that are estimated to cover around 300 million people. Both the vaccines will be administered; similarly, that is, in two doses. They are to be stored at standard refrigerator temperature 2 to 8 degrees Celsius. Initially, the country plans to vaccinate the 300 million frontline workers, elderly and vulnerable people by August 2021.
To ensure this supply, the Serum Institute of India has been mass-producing the vaccine. It thus has stockpiled over 50 million vaccine doses that are ready for distribution in India. The institute is ready to send these to approximately 30 to 40 government locations. The institute would then redistribute it to various small centers and clinics established for the mass vaccination program. To further ensure this rollout program’s success, the Indian government has been actively recruiting and training additional vaccinators and ramping up the stocks of cold–chain storage equipment like freezers, walk-in coolers, and ice-lined refrigerators in the past few months.
A dry run for COVID Vaccination Program has also been conducted on 2nd January 2021 at around 286 sites across India to familiarize officers at all levels regarding the operational guidelines. Concomitant with this, it is also revealed that over 114,100 workers have been trained to carry several tasks in addition to vaccination. These include verifying personal data, conducting cold chain and logistics management, and updating information using government software to ensure that every citizen of the country is vaccinated.
Currently approved COVID vaccines in India ( as of January 2021) :
The Indian drug regulators have approved two COVID vaccines for use in India. These are :
Covaxin is an indigenously developed vaccine produced by the Hyderabad – based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology. Covishield is another notable vaccine that is approved for use in India. The University of Oxford develops this vaccine in association with the pharma giant AstraZeneca. The Serum Institute of India is mass-producing it.
Both these vaccines can be stored at 2 to 8 degrees Celsius, the same as the domestic fridge’s temperature. They are administered in two doses between 4 and 12 weeks intervals.
Another vaccine that is notable for its immunization is the vaccine developed by Pfizer/ BioNTech. It is currently being administered in many countries apart from India. The exclusion of this vaccine from India is due to its challenge in storage as this vaccine must be stored at -70 degrees Celsius. Since the temperatures rise to over 50 degrees Celsius in India in summers, the Indian drug regulators have decided to forgo this vaccine’s use at the moment.
How to register for COVID Vaccination Program in India?
The COVID Vaccine Intelligence Network or Co:WIN system is currently being used to track enlisted beneficiaries for the COVID Vaccination Program on a real-time basis. Only pre-registered beneficiaries will be vaccinated as per the prioritization, and on-spot registrations are NOT available for this.
The steps for registering in Co – WIN system, a digitalized platform, are as follows :
Step 1 – Self-register on the Co-WIN website.
Step 2 – Upload any one of the following photo identification such as Aadhaar Card, Driving License, Health insurance smart card, issued under the government’s scheme, Official identity cards issued to MPs, MLAs, MLCs, PAN card, Passbook issued by Bank or Post office, Pension document and Voter ID among others.
Step 3 – If an individual chooses to provide an Aadhaar card as a Photo ID, the Co – WIN system will perform an Aadhaar authentication. The individual can select any one of the authentication methods from the following methods: Biometric, OTP Authentication, or Demographic Authentication.
Step 4 – Following registration, the system will allocate every individual the date and time for vaccination. This will be intimated to the individual via SMS on the registered mobile number.
Step 5 – At the vaccination site, only the pre-registered beneficiaries will be vaccinated. There is no option for on – spot registrations.
Step 6 – Before vaccination, a vaccination officer will use the Co – WIN application to verify the beneficiaries whom Aadhaar authentication has been done at the time of registration as per the guidelines. For those whose Aadhaar authentication has not been conducted, the officer will first authenticate this if the Aadhaar card number is available. In case the number is unavailable, then it will use other Photo IDs as per the guidelines.
Step 7 – Once the beneficiary details are authenticated/verified, they will proceed with vaccination. The individual’s vaccination status will be updated to ‘Vaccinated’ in the application by the vaccination officer after confirmation of the same from the Vaccinator officer.
Currently, the Co-WIN app is in the pre-product stage, and hence it is not available to download for the common public yet. Over 75 lakh health officials are already registered under this vaccination program. They will receive the vaccine at the initial stages of the vaccination. The vaccination sessions are planned to accommodate around 100 beneficiaries per session at fixed session sites. Mobile teams are being considered for vaccinating the individuals belonging to the high–risk population.
Cost of COVID vaccination in India?
Serum Institute has announced that it would price Covishield at 440 rupees ( about $3 ) for the Indian government and around Rs. 700 to 800 for the private market. The price of Covaxin that is developed by Bharat Biotech is still unclear. However, reports have suggested that the company will sell this vaccine at Rs. 350 per dose.
How long will it take for the vaccine to work?
It typically takes a few weeks for the body to produce T-lymphocytes and B-lymphocytes after vaccination. Therefore, it is possible that a person could be infected with the virus that causes COVID-19 just before or just after vaccination and then gets sick because the vaccine did not have enough time to provide protection.
Are two doses of the COVID vaccine necessary for protection?
It is necessary to get the two shots of the vaccine as the first shot starts building protection by helping the body recognize the virus and prepares the immune system for future encounters with the virus. The second shot further strengthens the immune system, which provides the most protection the vaccine has to offer.
Are Covaxin and Covishield 100 % effective against COVID?
The overall efficacy of Covishield is found to be 70.42 percent, which is well above the 50 percent threshold set by many drug regulators. The effectiveness of Covaxin is yet to be ascertained. However, clinical trials have revealed that it produces a robust and strong immune response once administered in two shots. Covaxin is an inactivated vaccine made of killed or dead coronavirus. This vaccine has been administered to over 22,500 volunteers in India to date, and it is found to be safe and healthy.
Is it necessary for a vaccinated individual to wear masks while going out?
Yes, CDC has advised people to wear masks and maintain social distancing despite getting vaccinated to reduce the chances of getting exposed to the virus or spreading the virus to others. Simultaneous implementation of these measures and getting vaccinated is believed to offer the best protection from COVID – 19.
Does immunity from COVID – 19 last longer than protection from COVID vaccines?
As COVID -19 is a relatively new virus, experts are unsure of the natural immunity conferred following the infection. This protection could vary from person to person but is not standard. Hence, the exact duration and efficacy of this are yet to be ascertained. However, current evidence has suggested that reinfection with the virus causing COVID -19 is uncommon within 90 days after the initial infection. Concerning the protection offered by vaccines, the duration of this is again unclear as further data are needed to elaborate on this. Nevertheless, it is advised to get vaccinated regardless of whether the individual was affected by COVID -19 or not.
Who should we report to if we develop adverse effects post-vaccination?
In anticipation of adverse effects that may manifest in people following vaccination, India’s Central government has asked all the states to set up ‘Adverse Event Following Immunization’ ( AEFI ) surveillance in districts. The state AEFI committee will look into the cause of the adverse effect and ensure that the patients with the adverse effects will be treated accordingly.
Is COVID vaccination mandatory in India?
No, COVID vaccination is not mandatory in India. However, all the citizens are advised to get vaccinated to protect themselves from the disease and reduce the chances of spreading the virus to others. For safety and precaution, it is advisable to register for COVID Vaccination Program.
Can a person having COVID -19 ( suspected or confirmed ) be vaccinated?
A person with confirmed or suspected COVID-19 infection may increase the risk of spreading the same to others at the vaccination site. For this reason, infected individuals should defer vaccination for 14 days after symptom resolution.
If one is taking medicines for illnesses like Cancer, Diabetes, Hypertension, etc., can he/she take the COVID – 19 vaccines?
Yes, people with one or more of these comorbid conditions are considered to belong to the high-risk category. Thus, they must also get vaccinated against COVID -19 at the earliest.
How will beneficiaries receive information about the date of vaccination?
Following online registration in the Co – WIN system, the beneficiaries will receive an SMS on their registered mobile number specifying the date, place, and time of vaccination. On getting the dose of the vaccine, the beneficiary will receive an SMS. After all doses of vaccine are administered, the beneficiary will also receive a QR code certificate to the registered mobile number.
Are there any preventive measures and precautions that one needs to follow at the session site?
The individual is advised to rest for at least half an hour after the vaccination. He/She must report any discomfort or symptoms to the nearby health care workers at the earliest.
CT Institute of Pharmaceutical Sciences, Punjab, Jalandhar; was established with an ambition to become an excellent center of Pharmaceutical Sciences and research in North India. Institute provides necessary infrastructure for promoting the research and development in the field. It has tie up with the renowned companies and industries for motivating practical experience and training. The institute has a very well qualified and experienced staff. The institute supports advancement for the students by providing exposure at the national and international forums. Most of the students bring fame to the institute with their meritorious performance.
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