COVID-19 VACCINE

Introduction


WHO is working in collaboration with scientists, businesses and global health organizations to speed up the pandemic response and to facilitate the equitable access and distribution of COVID-19 vaccines. As COVID-19 vaccines become available, the world must develop the infrastructure, supply chains, and distribution plans to introduce the vaccines at unprecedented scale and speed. Lessons from past vaccine implementations can guide an effective and equitable rollout strategy. Join our panel to examine lessons learnt from experience of introducing vaccines for malaria, meningitis and to discuss how these insights can enable efficient introduction plans for COVID-19 vaccines.

COVID-19 Vaccine R&D Blueprint


The R&D Blueprint is a global strategy preparedness plan that allows the rapid activation of R&D activities during epidemics. Its aim is to fast-track the availability of effective tests, vaccines and medicines that can be used to save lives and avert large scale crisis.


The current COVID-19 pandemic is unprecedented, and the global response has been drawn upon the lessons learned from disease outbreaks over the past several decades.


As a part of WHO's response, the R&D Blueprint was activated to accelerate diagnostics, vaccines and therapeutics for novel coronavirus. The Blueprint aims to improve coordination between scientists and global health professionals, quicken the research and development work, and develop new norms and standards to learn and improve upon the global response.


The current global public health emergency novel coronavirus underscores the need to accelerate the development of candidate vaccines. The working group for vaccine prioritization aims to provide aspirational guidance to vaccine developers from a public health perspective as well as to prioritize vaccine platform approach for candidates to be considered for further development. And then potentially consider them for the latest sage evaluation in the context of the global outbreak.


Overview of the Deliberations

Participants noted that there is no licensed vaccine for coronavirus and no established immunological correlation of protection. Several candidate vaccines have completed Phase 1 clinical trials against SARS-CoV and MERS-CoV. Participants noted however that the clinical development status of the various SARS-CoV vaccines and the potential availability of candidate vaccine stocks remains unclear and needs to be assessed.


Speed of manufacturing, size of batches, scale up options and process validation for production of commercial batches are key aspects to be addressed throughout the development plan and in view of the need for likely large-scale use.


Economic impact of COVID-19 vaccines on India


While the COVID-19 outbreak is directing a public health crisis, it has also caused substantial damage to the global economy. National governments are expending trillions of dollars to fight the negative economic impact, but until there is a vaccine or other treatment widely available, the financial cost will continue to dwindle all around.


Distant Socializing, the use of masks and test, track and trace programs are currently the only effective measures against the outspread of the disease, and economic sectors that rely on close geographical proximity, such as recreation and retail, will continue to be the most affected. Global vying or vaccine nationalism may prevent a COVID-19 vaccine from reaching those most in need. The unequal allocation of any vaccine could mean that vulnerable people in certain countries receive the vaccine after lower-risk individuals in other countries, leading to preventable deaths.


Investing in vaccine development and equitable access would be economically beneficial in the long run. Current spending by leading economies on vaccine development and allocation is relatively small compared to the economic loss associated with COVID-19 along with it makes business sense for them to invest substantially more in vaccine development and distribution. This approach could form the basis for boosting the global cooperative effort.


To uplift intercontinental sharing of vaccines, enforceable frameworks are required for vaccine development and distribution, managed by established international forums. Countries need to be bound by an agreement and not feel that they can limit supplies again when it suits them.


The international effort to support vaccination distribution needs to be sustained over time and will probably extend beyond most political cycles. As such, global cooperation could also help to take short-term thinking out of decision-making and focus on the long-term aspirations for the health of the universal population and economic development.


Vaccine nationalism could cost the global economy up to $1.2 trillion a year in GDP. As long as there is no vaccine against the disease, the global cost associated with COVID-19 and its economic impact could be $3.4 trillion a year. If the penurious countries cannot access vaccines, the world could still lose between $60 billion and $340 billion a year in GDP.


For every $1 spent on supplying poorer countries with vaccines, high-income countries would get back about $4.80. All affluent countries, along with countries such as India, China, and Russia, would still incur together an estimated GDP loss of about $119 billion a year, or approximately $10 billion a month. The EU would lose about $40 billion a year, the US $16 billion, and the UK between $2 billion and $10 billion.


Manufacturing, safety and quality control measures of the vaccination


A particular form of development for their individual vaccine parallels the potential vaccines.By exposing the body's immune system to the tiny fragments of the virus, the Pfizer/biotech vaccine creates immunity inside the human.It is said that a person is given a dose of 2 vaccines within a 21-day period.There are 5 doses of 0.3 millimetres in each vial of the vaccine.The preparation and transfer of the vaccine is the most complex aspect of the vaccine and the greatest hurdle in the Pfizer/Biotech vaccine; to remain viable, the vaccine must be stored at a temperature of-70 Celsius.


To ensure the safety of transportation, Pfizer manufactures special containers with dry ice, thermal sensors and GPS trackers.After two doses, the vaccine appears to have 95% efficacy.


A coronavirus vaccine known as ChAdOx1nCoV-19 or AZD1222 has been developed and tested by the University of Oxford and the British-Swedish company AstraZeneca.Unlike the Pfizer vaccine, it only guarantees a 90 percent chance of efficacy.India is currently using 'Covishield' for this vaccine.


Covishield also has a very different approach to the Pfizer vaccine; the use of chimpanzee adenovirus known as ChAdOx1.The vaccine should be kept at a temperature of 2-8 Celsius and should last at least 6 months.The vaccine also needs 2 doses given 4 weeks apart, and this vaccine is used in the first immunization process in India due to its low storage costs.Due to the latest creation of the vaccine, the percentage of success studies is not proven since the first dose is said to have more immunity than the two doses combined.


The entire vaccination process will be under the government's strict guidance, and from frontline health workers to borderline protection, the immunization process will begin.


FAIR AND EQUITABLE DISTRIBUTION OF VACCINE


2020 was one of the most unprecedented years which not only introduced this world with the coronavirus but also acquainted us with the new normal i.e., face masks, contactless economy and quarantine as a deliberate strategy to counter the virus. The world has been long enveloped by a global health emergency that is exacting enormous medical and economic tolls upon humanity. Vaccination to this brutal virus is the sole way to overcome the present situation. But there are several questions in the mind of the general public that need to be addressed.


Is the vaccine developed? Who would be the first person to get the vaccine? Whether or not the vaccine will show its effectiveness without any side effects?Among these the most important yet an answered question is "How would the government ensure a fair and equitable distribution of the vaccine?"


Presently 9 prominent Covid-19 vaccines have been rolled out globally and are expected to take this world out from the clutches of the deadly virus and the vicious circle of the economic recession. This virus has already claimed more than 2 million lives and is expected to shrink the global growth by a massive 8%. In India Covid-19 has made a ferocious impact, claiming 152K + lives, leaving millions unemployed and sinking the GDP. To avoid further deterioration of the already alarming situation, vaccination drive is an immediate necessity.


Vaccination protocols in India


Being one of the most populous nations and one of the biggest democracies of the world it is necessary for India to follow a systematic protocol so that two shots of vaccine can easily be provided to each citizen. Hence, the government has decided to use technology to maintain data and make the process easier.


The Covid-19 Vaccine Intelligence Network (Co-WIN) system, a digital platform will be used to track the beneficiaries for vaccination on a real-time basis. The Co-WIN app, will be used for registrations for the vaccine. This will be done from Covid Control Room (CCR) which has been set up in Nirman Bhawan in New Delhi. The app will provide information on vaccine stocks, storage temperature and track beneficiaries. The Centre will also tap beneficiary dropouts, sessions planned versus sessions held and vaccine utilization.


The beneficiaries will get information of the date, time and venue of their vaccination appointment on their mobile. After this the individual will be allowed to enter the vaccination hall after proper verification. Then the individual would be verified on the basis of photo ID card and unavailability of such ID would mean no vaccination. After verification they would be asked to sit in the waiting room with proper social distancing measures. When their turn comes the individual would be asked to go to the vaccination room where the officials would make the patient comfortable and aware of the vaccine. The beneficiaries would be free to ask their doubts. After the vaccination process the individual would be asked to wait in the observation room where they would be monitored. In case of any emergency they would be medically assisted.


If they feel fine they would register their data on the Co-WIN app and would be discharged. Further information about the next dose would also be provided on the same app. Once vaccinated, the beneficiaries registered on Co-WIN will get a QR Code-based vaccination certificate too. If in case the beneficiary faces any health problem then a proper number i.e., 104 is provided to get immediate assistance.


This well defined procedure is being followed by the GOI to make the nation immune to Covid-19. Problems may arise as the vaccine is rolled out in rural areas. It is impossible for the government to provide free vaccines to all rural people. To make the distribution equitable the government must subsidise the vaccine for the poor.


Potential Companies to develop Vaccinations:


Pfizer and Biotech

Pfizer's Covid-19 vaccine called comirnaty (BNT162b2) has become the first vaccine to get approved and has started being delivered in The United Kingdoms. It is the first time that messenger RNA (mRNA) code is being used to help the body root and fight the virus.


The company will decide the price of the vaccine with respect to their GDP, for example: the price for US will be $19.50 for 1 dose whereas it will be tiered for middle-income countries like India. India faces an added difficulty in procuring this Vaccine as the country lacks -70°c which lacks in India's cold storage facilities.


Moderna

The Moderna covid-19 vaccine is a two-dose mRNA code based vaccine developed by Moderna and NAID(National Institute of Allergy and Infectious Diseases). For Clinical Stage Developments BARDA gave $955 million to Moderna.


Sinovac

The Vaccine developed by the Chinese Biotech Giant is called Coronavac. This Vaccine is specially as a part of the emergency program for "high risk" individuals such as health care workers. Investments in Sinovac were made by Advantech Capital and Vivo Capital of around $15 million and Sino Biopharmaceutical purchased 15% stakes for about $500 million for development purposes of the vaccine.


Sinopharm and Wuhan Institute of Virology

This is an inactivated and unnamed vaccine candidate used by China as part of their emergency plan for " high risk" individuals vaccination programme. This vaccine has a "strong neutralizing antibody response". It’s development was in assistance with The Ministry Of Science and Technology in China.


AstraZeneca

AstraZeneca covid-19 vaccine AZD1222 is developed by AstraZeneca along with oxford vaccine group. This Vaccine will be sold in India by the name of “Covishield” being developed jointly by the Serum Institute of India. BARDA and OWS sponsored the trials for it. Around 300 million doses were ordered by OWS for The United States of America for about $1.2 Billion


Gamaleya Research Institute

The Gamaleya Research Institute jointly with The Health Ministry of Russian Federation developed this non-replicating viral vector vaccine Sputnik V. It was the first government vaccine but due it's fast-paced development it received a lot of criticism and the lack of data about it put several question marks on the safety of this vaccine


Sinopharm and Beijing Institute of Biological Product

Another inactivated vaccine is being developed by Sinopharm called BBIBP-Corv,

In partnership with the Beijing Institute of Biological Product. It was approved by China on 30 December after it's phase 3 trials showed 79 percent efficiency. Along with China, UAE, Bahrain and Egypt have also made this vaccine part of their emergency program.


The Vector Institute

EpiVacCorona is a peptide vaccine developed by the Federal Budgetary Research Institution State Research Center of Virology and Biotechnology. Yet again this Russian vaccine received a lot of criticism for its third phase trials. It's first and second phase trials were sponsored by The Vector institute.


Bharat biotech

Covaxin became India's first indigenous Covid-19 vaccine which is developed by Bharat Biotech in collaboration with Indian Council of Medical Research - National Institute Virology. It is manufactured in Bharat biotech's BSL-3 high containment zone. Now, along with covishield, India has a second vaccine to roll out in the country.


Apart from these vaccines, there are other vaccines which are still in the development stage. Convidicea by Cansino Biologics, JNJ-78436735 by Johnson and Johnson, NVX-cov2373 by novavax, INO-4800 by inovio pharmaceuticals are some of the vaccines which have reached the third phase of trials and are very close to getting approved.


COST


Any problem at scale cannot be solved by ignoring the economics of it. Same stands true for COVID-19 vaccines- Rich Nations with hefty pockets, can afford to shell out some more money, reserving the vaccines at first sight, however this creates a problem for low-income nations.


The pandemic, as warned by virologists, will end only when the majority of mankind in all geographics will be immunised, naturally or through vaccines


Currently 9 vaccines have been approved in total across the world, these include (with price)-

  1. Comirnaty (Pfizer- BioNTech) - $19.5

  2. Moderna Covid-19 Vaccine- $37

  3. CoronaVac- $10.3

  4. CoviShield- $ 3-4

  5. Sinopharm Covid-19 Vaccine- $145

  6. Sputnik-V- $10

  7. BBIBP CorV- $ (NA)

  8. EpiVacCorona- $(NA)

  9. Covaxin- $ 4-5

The prices of these vaccines vary wildly, however so does their efficacy.


But Where does the difference in price come from?


Storage requirements

Pfizer biotech and moderna vaccines require temperatures of -70°C, this is not easy to achieve and hence the price is nearly fourfold of adenovirus vaccines.


Location of production

Vaccines produced in western countries attract higher wages, material cost and others whereas covishield is produced at less cost. It can also be understood with the help of the PPP concept.


Scaling effect

This is where things get a bit tricky, consider the already lowly priced vaccines, here the vaccines are already cheap, however if you add the economics of scale, you can get them to be cheaper. Now consider the expensive moderna and pfizer counterparts, these vaccines are already expensive and even after scaling up the production it won't be as cheap as it’s substitutes. Therefore, the expensive stay-relatively expensive, however the cheaper vaccines get cheaper, and thus offer more opportunity to itself in number of orders.


Country of ideation and research

Developed countries like The USA and several European nations attract high cost for equipment and other material costs, it is advertently related to the general cost of living.


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