In-depth | COVID-19

The what, why and how of the COVID-19 vaccines

By - 28.06.2021

And why you should take it.

Over 100,000 people have been infected and over 2,000 people have died of COVID-19 in Kosovo. In February 2021, Kosovo doubled its expected death rate for that period. This is only a small slice of the nearly 4 million dead and close to 180 million infected globally. 

Since Kosovo finally received its first batch of vaccines in March, over 125,000 people have had at least one dose and over 7,000 have had two doses. 

What are these vaccines and how do they work? Are they safe? And will they really end the pandemic? 

But first, a little general background on vaccines:

A vaccine, very simply, is a biological preparation that stimulates the body’s immune response. 

Humans have used vaccines or vaccine-like interventions for thousands of years. Some of the earliest examples date back to China, Africa, India and the Ottoman Empire. In 1721 Lady Mary Wortley Montagu, a memoirist and wife of a British diplomat, brought smallpox inoculation to London from the Ottoman Empire and vaccinated her own daughter. 

She was denounced by the British medical establishment, but later vindicated when, in 1796, British physician Edward Jenner created a smallpox vaccine using similar principles to Lady Montagu’s inoculation. Today smallpox has been totally eradicated.

What are the COVID-19 vaccines?

Right now there are seven vaccines in wide usage throughout the world: Moderna (US), AstraZeneca (UK, Swedish), Pfizer BioNtech (U.S. and German), Janssen (US, Belgian), Sinovac (Chinese), Sinopharm (Chinese) and Sputnik V (Russian).

Moderna, Pfizer, Janssen and AstraZeneca are authorized in Europe by the European Medicines Agency (EMA) for adults.

Moderna, Pfizer and Janssen are authorized in the United States by the U.S. Food and Drug Administration (FDA) for adults. Pfizer is now authorized for adolescents between 12-18 in the United States.

Sinopharm is in use in some European countries, like Albania, Serbia and Hungary, and has recently been approved by the World Health Organization (WHO). This means it can now be distributed globally by the COVAX vaccine distribution network. Sinovac has also been authorized by the WHO.

What's a COVAX?

The COVAX initiative is the COVID-19 vaccine alliance, an organization that distributes vaccines for low and middle income countries as well as providing a cooperative vaccine buying mechanism for higher income countries. It was created to ensure that COVID-19 vaccines are accessible to everyone, not just the rich.

COVAX is made up of GAVI, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), the WHO and UNICEF as the implementing agency. GAVI has been around for 20 years making vaccines available cheaply or for free to low income countries.

GAVI finds the donors and estimates the needs of individual countries. CEPI works with pharmaceutical companies on vaccine research and development. The WHO helps with verifying and certifying vaccines and UNICEF works on distribution and buying.

The European Union is the second largest donor to COVAX after the U.S., which pledged $4 billion to the effort on February 18.

According to the Kosovo National Deployment and Vaccination Plan for COVID-19 Vaccines, Kosovo will accept all vaccines authorized by the EMA or the FDA.

Dr. Angela Rasmussen, a world leading virus expert based at the University of Saskatchewan, explained in February that multiple vaccines are needed because of handling issues and because different populations may have different responses to various vaccine varieties.

The Janssen vaccine, also known as the Johnson and Johnson vaccine, is one dose and can be held at normal refrigeration temperatures, making it easier to distribute across the world. Pfizer and Moderna vaccines require two doses and deep freeze temperatures, which require specialized equipment that not all countries have. AstraZeneca, Sinopharm, Sinovac and Sputnik V do not require the specialized deep freeze refrigeration.

Speaking primarily about the Moderna, Pfizer, AstraZeneca and Janssen vaccines, Rasmussen said, “the good news is, they’re all relatively efficacious at preventing symptomatic disease.”

Experts say that any vaccine with an efficacy of 50% is worth taking.

The WHO currently has 15 vaccines under review or approved for the Emergency Use Listing (EUL) process, including the seven most widely used vaccines. The EUL opens the door for national regulatory agencies to proceed with their own evaluations. The WHO’s recommendations are not binding for individual countries. 

A leading Chinese official has admitted that the Sinopharm and Sinovac vaccines have low effectiveness compared to others currently on the market. This may mean requiring a third dose or a combination with another vaccine. But many experts say that any vaccine with an efficacy of 50% is worth taking. Both Chinese vaccines meet or exceed this threshold according to recent studies.

However, more questions about the efficacy of the Sinopharm vaccine have come up recently. In the Seychelles, a small island nation in the Indian Ocean, 57% of people took the Sinopharm vaccine and infections have increased so much that restrictions had to be reinstated

Breakthrough infections and increased transmissions have also been seen in Mongolia, Bahrain, Chile, Indonesia and the United Arab Emirates, all countries that depended on Sinopharm and Sinovac.

There are currently 93 vaccines in the human research phases right now.

How can we be sure they are safe?

Some people are concerned because the vaccines came out much faster than usual. Normally it takes 5-10 years for a vaccine to be approved and be put on the market. This time it took just under a year largely because many scientists dropped everything else while governments, private organizations and individuals put huge amounts of money into the research and development of vaccines and governments cut bureaucracy to expedite the process.

But much of the science behind the new vaccines has been in development for years. The messenger RNA or mRNA technology for vaccines, which the Moderna and Pfizer vaccines use, has been studied since 1978 by the pioneering Hungarian scientist Katalin Kariko among others. 

No steps were skipped in making the vaccines and all safety measures were taken. Courtesy of the World Health Organization.

The vaccines have been tested thoroughly. Thousands of people were tested during the clinical trials for AstraZeneca, Pfizer, Moderna and Janssen, just as would be the case for any other vaccine. These four vaccines have gone through all three clinical phases plus one preclinical phase. Now they have been given to millions of people and the safety system continues monitoring during the mass vaccination stage.

Like many vaccines, including the flu shot, scientists think that people will need booster shots or an annual shot to maintain protection because of the virus’ variants.

All viruses mutate and have variants. A mutation simply means there is a change in the genetic makeup of a virus. A variant is a virus whose mutations have changed how it works. The more a virus spreads, the more likely it is to develop mutations and create variants. Some of these will be dangerous and some not. Vaccine manufacturers have begun to take this into account. 

The only way to stop the spread of COVID variants is to ensure that as many people as possible get vaccinated.

Right now, experts believe that most vaccines will stand up to the variants currently in circulation, like the Alpha and Beta variants in Kosovo or even the Gamma variant that is currently devastating Brazil.

The Delta variant — which caused havoc in India, delayed the full lifting of lockdown measures in the UK and is now spreading in Russia — is thought to be 60% more virulent than the Beta variant. 

The spokesperson for Kosovo’s Ministry of Health, Dr. Faik Hoti, told K2.0 that in Kosovo “there are still no cases of the Delta variant. Currently the situation is calm and with a few cases, but care should not be reduced, on the contrary.”

The only way to stop the spread of this and other variants is to ensure that as many people as possible get vaccinated and continue to maintain public health recommendations: masking indoors, keeping indoor spaces well-ventilated, avoiding crowds and limiting close contact with people outside your trusted circle.

Hoti emphasized that government restrictions dictate that the only time you should not wear a mask is when walking alone, playing sports or eating and drinking.

Can the vaccine give you blood clots?

It can, but it is extremely rare. According to the EMA and the Medicines and Healthcare Agency, the vaccine oversight body for the UK, the AstraZeneca vaccine has an extremely rare side effect that causes blood clots in certain people. Out of 2.7 million people in Germany who took the vaccine by March, 31 had this complication. Nine died. All women.

On April 13, a similar blood clot issue was noticed among recipients of the Janssen vaccine in the United States, causing the U.S. government to pause vaccinations “out of an abundance of caution.” Over 7 million people have received the Janssen vaccines and eight people became ill with a rare cerebral blood clot resulting in one death. 

Experts and scientists agree that getting COVID-19 is far more dangerous than any vaccine.

The EMA approved its usage on April 20 saying the benefits outweigh the risks and the U.S. has resumed using it as well.

The Kosovo Ministry of Health reported that there have been no major side effects from vaccines to date.

Germany and France have decided not to use AstraZeneca for people under 60 and 55, respectively. The UK offers people under 30 a different vaccine. Norway suspended AstraZeneca use and Denmark has dropped it altogether.

But most experts and scientists agree that getting COVID-19 is far more dangerous than any vaccine. Dr. Rasmussen points out that vaccine pauses and restrictions actually show how well the safety system is working.

As Devi Sridhar, Professor and Chair of Global Public Health at Edinburgh University Medical School, said, “If anyone offers you a vaccine, smile, roll up your sleeve and hold out your arm.”

What is mRNA? What is an adenoviral? What is a viral vector?

All of these are different ways vaccines induce immunity.

The Moderna and Pfizer vaccines use mRNA technology to send a message to your cells. This message teaches them how to make a protein that triggers an immune response inside our bodies. The resulting antibodies are what protect you from getting sick.

Vaccines like AstraZeneca, Sinopharm, Sinovac and Sputnik V use an adenoviral or viral vector. These are made up of a DNA strand or a dead coronavirus that basically sends a message to your cells that it is time to fight off the COVID-19 infection. 

How mRNA vaccines work.

The vaccines do not change your genetics or DNA, they also do not contain a microchip and they are halal, kosher and “morally acceptable,” according to the Vatican. They do not affect your fertility and are not dangerous for pregnant women.

Unfortunately, they do not improve your WiFi.

None of the vaccines guarantee that you won’t catch and spread the virus, though recent studies show that they cut down on the risk of transmission. What we do know is that the vaccines prevent the vaccinated from getting sick. 

In a study from 2020, a majority of people with COVID-19 could not say where or how they caught the virus. Many experts suspect that the majority of spreaders are asymptomatic, meaning they have no symptoms and probably don’t know they are contagious. This may include the vaccinated.

"Until we are all vaccinated, no one is safe."

Arben Vitia, Kosovo Minister of Health

So people who are vaccinated still need to mask (especially indoors and in crowds), socially distance and wash their hands regularly in order to not spread the disease to others who have not got their jab yet.

As Kosovo’s Minister of Health Arben Vitia said in an April 13 media conference, “until we are all vaccinated, no one is safe.”

When will Kosovars get their vaccines?

While many countries began vaccinating their population in earnest in early 2021, Kosovo only received its first few doses in late March.

So far most of the vaccines Kosovo has received have been from COVAX, paid for by the EU.

UNICEF, an implementing partner for COVAX, told K2.0 that the vaccine distribution network will cover 20% of people in Kosovo by the end of this year

Countries like Austria, Croatia and Norway have individually donated vaccines to Kosovo and the broader region. Austria will donate another 1 million doses to the Western Balkans by August. 

The EU has given 70 million euros to Western Balkan countries to buy vaccines. Out of this, Kosovo received 7,030,070 euros to purchase approximately 700,000 doses on re-sale from EU member states. The first 95,000 were bought from Austria and are to be delivered in August. 

The U.S. has announced plans to share over 80 million surplus vaccines over the next year. Kosovo and Bosnia are included on the list of intended recipients. According to the Bosnian government, they will receive 500,000 of these vaccines. It is not clear yet how many Kosovo will get. These vaccines are supposed to arrive by the end of June.

The Kurti government announced in late May that it signed a deal for 1.2 million Pfizer vaccines to arrive by the end of 2021. 

Flowcharts like this are used to prioritize groups of people with urgent needs for vaccines. Courtesy of Medethics.

In the government’s roll out plan, health workers and the elderly are first in line for vaccines along with people who have chronic diseases. Currently, people over the age of 65 and people with chronic diseases are prioritized, while teachers and security officials are being vaccinated as well. However, the government has invited everyone in Kosovo to apply for the vaccine online at the eKosova platform. 

The Ministry of Health, according to their spokesperson Dr. Hoti, has heard many complaints regarding the vaccination registration process. He said that the ministry has taken steps to simplify the process — including scrapping a requirement to photograph yourself with your ID — all in order to get the process of applying and making an appointment down to 2 minutes. For those who need it, there is a free phone number for questions: 0800 30 900.

Though there have been claims that younger people without proof of chronic disease have received vaccines, Dr. Hoti said that they are requiring clear proof of chronic disease and that there is a doctor at every vaccination center to evaluate evidence brought forward by patients. 

Even “public figures” who did not have adequate proof have been turned away, said Hoti. Though the ministry doesn’t dispute that some individual cases may have slipped through, Hoti said he believes “the absolute majority” respects the rules.

Kosovo’s government says that it hopes to inoculate at least 60% of the population by the end of this year.

Additional exceptions are made for Kosovars who need to be vaccinated in order to receive medical treatment abroad, or if a Kosovar risks losing study abroad or scholarship opportunities.

While many Kosovars, mainly those from the Serb community, went to Serbia for vaccination, Hoti said, “The Ministry of Health wants to see as many vaccinated citizens of Kosovo as possible, regardless of which community they belong to.” He also noted that the government has offered vaccinations to Kosovo residents from the Presheva valley.

No decision has yet been made about vaccinating people under the age of 18. The ministry said that this decision will follow the guidelines of the WHO, EMA and the U.S. Centers for Disease Control and Prevention.

Hoti added that from the last week of June and onwards more vaccines will begin arriving in Kosovo as a result of the donations and the Pfizer contract.

Kosovo’s government says that it hopes to inoculate at least 60% of the population by the end of this year. 

How will vaccines reach everyone?

Carrying out a mass vaccination plan is difficult anywhere as we are seeing throughout the world now. So how is Kosovo working to ensure that all citizens are vaccinated?

For now people are invited to apply for a vaccine on eKosova. But to ensure access and uptake for minority groups, the disabled, the elderly and vaccine skeptics, more steps may need to be taken.

Dr. Faik Hoti, the Ministry of Health’s spokesperson, said they will begin offering mobile vaccination to the disabled and to the housebound. They are also planning to send volunteers to the homes of Roma, Ashkali and Egyptians to help them apply on eKosova in addition to other outreach activities.

To combat vaccine hesitancy, the ministry began an outreach campaign with key influencers, health professionals and “evidence-based data.”

For all citizens needing a “vaccine passport,” a QR code will be given as proof of vaccination. The QR code will link to the COVID-19 portal that can be read anywhere and by any authority.

How come we have so few vaccines and rich countries have so many?

One issue is supply. There aren’t yet enough doses for everyone and vaccines are hard to produce. But the key issue is that rich countries are buying up huge amounts of vaccines before they are even made.

As of March, high-income countries had bought over 5.9 billion doses of the available vaccines, and by September the U.S. will have 500 million surplus vaccines, according to the Brookings Institute. 

COVAX has signed contracts for 2.8 billion vaccines from manufacturers that will take it through 2022. According to Duke University’s (U.S.) Global Health Innovation Center Speedometer, there will not be enough vaccines to cover everyone in the world until 2023 or 2024.

High-income countries have bought and reserved many more vaccine doses than needed for their population sizes, monopolizing the market. Courtesy of Duke University Global Health Innovation Center.

Additionally, India, one of the largest producers of vaccines in the world, halted exports of AstraZeneca vaccines earlier this year when a deadly second wave hit the country.

The WHO and other organizations are campaigning for the richest countries in the world to begin donating vaccines and sharing patents, materials and formulations to allow more manufacturers to make vaccines and distribute them more widely.

The Biden administration changed its mind and has recently come out in favor of waiving vaccine patents. However, the EU, and particularly Germany, are still against the waiver.

Moderna has never enforced patents on its vaccine. But even if the EU did agree to share patents, it will take years to build up the capacity to produce vaccines. Moderna’s CEO added that it will take some time before vaccine manufacturers across the globe are able to replicate their process or that of any other mRNA vaccine.

The G7 — the leading group of economies in the world — have agreed to donate 1 billion vaccines to poorer parts of the world over the next year. The U.S. plans to buy and donate 500 million Pfizer vaccines over the next year through COVAX.

Meanwhile, Serbia has become central to vaccine distribution in the region. It was at one time the nation with the second highest level of vaccinations in Europe. Serbia offers AstraZeneca, Pfizer, Sinopharm and Sputnik V vaccines to its citizens. To combat vaccine hesitancy it has begun paying its citizens 3,000 dinars, about 25 euros, to take the jab. 

The Serbian government has now opened its vaccination centers to citizens of Bosnia and Herzegovina. Kosovo citizens have been eligible to be vaccinated in Serbia since last December.

Now Serbia will begin producing the Sputnik V and Sinopharm vaccines to sell regionally and globally. Sputnik V has not yet been authorized by the WHO. 

Is the pandemic over? We asked Dr. Hoti. “Certainly it is not over,” he said. “People all over the world need to work together and in solidarity to face this global challenge, but it still takes time, patience, extra care and a faster vaccination process.”K

Feature image: Atdhe Mulla / K2.0.