COVID-19 Vaccine Trials: Everything that You Need to Know

 

COVID-19 Vaccine Trials: Everything that You Need to Know

Despite the advancements in sciences and technology, there are some situations where human knowledge is limited, and the struggle to find answers starts from zero. The same thing happened when coronavirus first emerged as a novel virus, which soon became a public health threat. Originally believed to be a bat-transmitted virus, it took nearly one year for the researchers to understand this virus to an extent. It is believed that there is a need for further investigation on the virus as the information on it is still lacking, and it keeps evolving. Some British scientists have warned that coronavirus has experienced nearly 4000 mutations and all of these mutated strains possess a threat to human health. So, where is this situation going, and more importantly, is there a way to stop it?

The simple answer to this is that no one really knows it yet. Still, the medical community and the general global population have high expectations from the ongoing COVID-19 vaccine trials. The race to develop a COVID-19 vaccine has already started, yet many things are not clear to people. Pfizer/BioNTech’s 90% efficient vaccine to Moderna/NIH’s 95% efficient vaccine more than 20 vaccine candidates are working to develop the best vaccine. Judging this development process's speed, it looks like the COVID-19 vaccine will probably be the world’s fastest developed vaccine.

Now that all of these developers are trying to create and test the most efficient COVID-19 vaccine, it is necessary to understand how a vaccine can finally end this pandemic.

COVID-19 vaccine trials

What is it a vaccine?

Vaccine is the ‘memory’ of a virus that the human body uses to identify and detect in case of a pathogenic attack. Injecting a vaccine helps the body prepare the body to battle against a pathogen that may cause an infection. The body saves this memory of the pathogen from the vaccine, which helps build immunity without exposure. So, when the actual pathogen attacks it, the body can fight back and save itself.

The same is true for coronavirus. If this vaccine is available anytime soon, it will help people develop immunity against the virus without contracting the infection. That is why creating a vaccine against this deadly pathogen seems to be the ultimate and permanent solution for the ongoing pandemic.

 

Benefits of receiving COVID-19 vaccine

The ongoing COVID-19 vaccine trials analyze the efficacy of a target-specific vaccine that attacks the spike protein in coronavirus outer surface. The term ‘coronavirus’ is from these spikes or crowns like structures on its body, which gives it a distinct appearance. Ideally, the COVID-19 vaccine shot will trigger the body to remember this pathogen and build up resistance. This is to stop the SARS-CoV-2 (coronavirus) from entering inside the body, invade it and start replicating. Interestingly, no person can get COVID-19 from this vaccine despite it having the same pathogen, coronavirus.

According to the U.S. Centers for Disease Control and Prevention (CDC), vaccines' availability will reduce a person's chances of getting infected. It will even save other people around a person to get the virus. But before expecting all this, the clinical trials of the COVID-19 vaccine must ensure maximum efficiency and safety, after which the vaccine will be approved for public use. For this reason, some leading pharmaceutical companies are testing their COVID-19 vaccines in phase three/clinical trials.

COVID-19 vaccine trials

Companies racing to develop COVID-19 vaccine

The vaccine’s clinical trials refer to the methods through which its efficiency and safety are tested. Usually, vaccine development projects are lengthy, and for most vaccines, it takes years to get a desirable product. But this year, 2020, is not normal in any way.

The US government has invested billions of dollars in getting a vaccine to end this pandemic, which has killed 268,949 in the country to this day and infected over 13,197,307 people. While there is still no information on which vaccine the candidate will get the approval from the U.S. Food and Drug Administration first, knowing that top pharmaceutical companies are struggling to create one is reliving.

Here is a list of the top six vaccine candidates in phase three of the COVID-19 vaccine trials.

 

COVID-19 vaccine trials

o   Novavax

Novavax is a biotech company that has developed a building capacity of nearly 2.75 billion coronavirus vaccine doses of its product NVX-CoV2373. It has acquired another pharma company, Praha Vaccines, for a whopping 167 million dollars. The manufacturing unit of Praha Vaccines is located in the Czech Republic, which is now operational under Novavax and aiming to produce at least 1 billion vaccines in 2021. It has also signed new deals with two other companies AGC Biologics and PolyPeptide Group, which will be providing a unique adjuvant ‘Matrix-M’ which is needed for developing the vaccine.

In July 2020, Novavax has also signed a contract with another big company FUJIFILM Diosynth Biotechnologies, to produce 500 to 600 million vaccine doses yearly. The US Government has pre-ordered 100 million doses of this NVX-CoV2373 from Novovax, worth $1.6 billion.

COVID-19 vaccine trials

o   AstraZeneca/Oxford

AstraZeneca is a European pharmaceutical company which is aiming to produce 2 billion vaccine doses in 2021. US Government has paid $1.2 billion for 300 billion of AstraZeneca coronavirus vaccine. The company has bonded with 20 different contract manufacturing organizations (CMOs) worldwide. Both Novavax and AstraZeneca has signed an agreement with Serum Institute of India for manufacturing 1 billion vaccine doses after it gets approval from US regulators. These manufacturing units and numbers are continuously increasing, and as per critics, AstraZeneca is targeting to cross 3 billion doses next year.

 

o   Pfizer/BioNTech

Pfizer, along with its German partner, BioNTech is working to develop an efficient COVID-19 vaccine. Both Moderna and Pfizer are targeting an mRNA vaccine, which might possess serious distribution problems. These mRNA vaccines are stored at -94 degrees Fahrenheit throughout its shipment and storage, nearly impossible. These high distribution standards might cause problems in its distributions later. Pfizer has shared that its vaccine is 90% efficient, and it will soon get FDA approval. The U.S. government has invested $1.95 billion in Pfizer/BioNTech vaccine by ordering 100 million doses.

 

COVID-19 vaccine trials

o   Moderna/NIH

Moderna is a Biotech company that has signed a 10-years long deal with Lonza Group to make mRNA-1273 (coronavirus vaccine) and other vaccines in the future. The critics estimate that Moderna’s production will easily cross 1 billion doses, but its final target is to reach 500 million doses. A few weeks ago, Moderna shared the results from its phase three trials declaring that its vaccine is up to 95% efficient, which is by far the best result among all other companies. The company has cut a $1.5 billion value deal to deliver 100 million doses as soon as possible

 

o   Sanofi/GlaxoSmithKline

Sanofi and GlaxoSmithKline collaborated to score a massive $2.1 billion deal with the US government to provide 100 million doses of the COVID-19 vaccine. Sanofi is already conducting the vaccine trials and producing the vaccine on its own. While GlaxoSmithKline is working on an adjuvant that will co-work with this vaccine and boost immunity. This partnership plans to manufacture1 one billion doses of coronavirus vaccine annually.

 

COVID-19 vaccine trials

 

o   Johnson & Johnson

Johnson & Johnson is among the first companies which received the research and development grant from the US Government to work on COVID-19 vaccine trials. The company has shared its aim to manufacture and deliver 1 billion doses within one year. Five months ago, Johnson & Johnson partnered with a contract manufacturing organization (CMO), Emergent BioSolutions, for $480 million worth of orders. This partnership will provide billions of vaccine doses in the next five years.  The company has also agreed with the US government to deliver 100 million doses to the U.S. population for $1 billion.

 

Controversial COVID-19 vaccines

While companies share their phase three COVID-19 clinical trials, other vaccine candidates promote their product without a safety evaluation. The Russian vaccine, Sputnik V, had received criticism from the medical community around the world when it announced ‘results’ of its clinical trials precisely two days after Pfizer/BioNTech released strong evidence on how a vaccine can save from coronavirus.

The Gamaleya National Center of Epidemiology and Microbiology, Moscow Russia, said that their vaccine has proven 92% effective. However, this vaccine received criticism when Russian President Putin announced on national TV on Aug 12 that Russia has registered the first-ever COVID-19 vaccine as it was approved for usage without completing the third and most crucial phase of a clinical trial.

On the other side, China has also developed an ‘unproven’ COVID-19 vaccine and used it on more than 1 million people. On one side, where companies are still testing their vaccines' efficiency, Chinese companies have already started to provide these vaccines to its residents under emergency use policy. Sinopharm and Sinovac are the two top Chinese companies who have developed their vaccines. The Sinovac vaccine was sold in Zhejiang province on a ‘first-come, first-serve basis for $60/ dose.

COVID-19 vaccine trials

COVID-10 vaccine development in Pakistan

Pakistan has also started phase three trials of its vaccine candidate. This month, a government scientist explained how Pfizer’s COVID-19 vaccine is not suitable for any developing country. Dr. Atta Ur Rahman, the chairman at Task Force on Science and Technology said that maintaining a high temperature for this Pfizer made RNA vaccine might be a massive problem in all these countries.

Many independent bodies are working on COVID-19 vaccine trials. One of them, developed under CanSinoBio in collaboration with partner Beijing Institute of Biotechnology, is now in its phase three trial, taking place in Russia, Argentina, China, Pakistan, and Chile. This trial is testing 40,000 people for this coronavirus vaccine (Ad5-nCoV), out of which 10,000 volunteers will be from Pakistan.

Currently, the Pakistani government is communicating with pharmaceutical companies to get a hand on COVID-19 vaccines. The trial registration is open for volunteers. These trials will take place at various locations, including Shifa International Hospital (Isb), University of Health Sciences and Shaukat Khanum Memorial Cancer Hospital and Research Centre (Lhr), and the Aga Khan Hospital and Indus Hospital (Khi). The Health Ministry has suggested to $150 million budget to buy the initial doses.

 

COVID-19 vaccine trials

Who will develop the COVID-19 vaccine first?

All of these companies have signed contracts with Operation Wrap Seeds to deliver the COVID-19 vaccine. Sanofi/GlaxoSmithKline has signed a deal for providing 100 million vaccine doses for $2.1 billion, followed by a $1.95 billion contract by Pfizer/BioNTech for delivering 100 million vaccine doses and a $1.6 billion deal by Novavax for producing 100 million vaccine doses.

The question of who will develop it first still has no answer. But Pfizer, Moderna, and AstraZeneca have announced the results of their phase three COVID-19 vaccine trails showing remarkable progress. Dr. Anthony Fauci, from the National Institute of Health and Infectious Diseases, urges to build realistic expectations from vaccines as there are many challenges to overcome even after a vaccine gets approval and is available in the market. They may also not be able to end the pandemic in a short time due to difficulties in availability and distribution.