COVID-19 vaccines

Part 2 | What you need to know about the COVID-19 vaccine manufacturers

Raizza P. Bello

This is AI generated summarization, which may have errors. For context, always refer to the full article.

Part 2 | What you need to know about the COVID-19 vaccine manufacturers
A look into the track record of Bharat Biotech, Moderna, Novavax, and Sinopharm

Part 1 | What you need to know about Pfizer-BioNTech, Oxford-AstraZeneca, Sinovac Biotech, Gamaleya National Center of Epidemiology and Microbiology, and Johnson & Johnson

As the number of COVID-19 cases continues to rise – 1,269,478, as of writing – the Philippines plans to start all adult vaccination by August, National Task Force Against COVID-19 chief implementer Secretary Carlito Galvez Jr. said in a June 1 press briefing.

The vaccine supply is projected to stabilize by July, he said, as negotiations with vaccine manufacturers for second-generation vaccines and booster shots are ongoing. The national government is also in talks with the governments of India, Israel, and the United States to further secure vaccine supply.

We profile several manufacturers – five in Part 1, and four in Part 2 – and touch on the complexities that come with the immunization rollout.

Bharat Biotech

India’s Bharat Biotech International Limited (BBIL) has been prominent in the field of vaccine manufacturing, especially for its focus since 1996 on research and development. It has at least 140 patents globally and has produced vaccine milestones, including JENVAC (for Japanese encephalitis), ROTAVAC (Rotavirus), and the world’s first Typhoid Conjugate Vaccine, Typbar TCV. 

In 2011, the company dealt with regulatory audits from the World Health Organization (WHO) for failing to meet manufacturing quality, practices, and standards for its vaccines, such as the one for Hepatitis B. 

BBIL’s most recent investment, in collaboration with the Indian Council for Medical Research, is the indigenously grown COVID-19 vaccine Covaxin. The company is yet to release findings from the vaccine’s phase 3 trials, but it already received restricted emergency approval in India in January 2021. This initially raised doubts among experts about the regulatory process of the vaccine. However, data in earlier trials showed Covaxin’s safety and efficacy. 

BBIL also recently faced online attacks from the Chinese hacking group APT10, otherwise known as Stone Panda, which generated concerns about intellectual property theft.

Currently, the Philippines is awaiting an estimated eight million Covaxin doses, following agreements and the grant of emergency use authorization (EUA) in April.

Moderna

Formerly known as ModeRNA Therapeutics, American drug maker Moderna has concentrated on developing vaccines and medicines using novel messenger RNA (mRNA) technology. From 2010 onwards, the company has had over 240 patents worldwide for its mRNA programs and has developed several vaccine candidates, at times in collaboration with pharmaceutical enterprises such as AstraZeneca and Merck. 

A few years ago, the emerging biotech firm got entangled in a legal dispute pertaining to delivery technology licensing. Its executives also faced allegations of manipulating the stock market in 2020, right after Moderna declared positive results in its coronavirus vaccine phase 1 clinical trials. 

To develop the COVID-19 vaccine, the company received huge funding from the United States federal government. The vaccine, formally called mRNA-1273, is being used in America’s mass vaccination, together with Pfizer’s and Johnson & Johnson. 

Moderna is the second pharmaceutical company to successfully produce coronavirus shots for teenagers. The May 2021 safety update of the US Centers for Disease Control and Prevention (CDC) cites reports about adolescents and young adults experiencing myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) after vaccination. The CDC is monitoring the cases and advising the public to still get inoculated, as the benefits outweigh possible risks of vaccination. 

In May, Moderna’s mRNA-1273 became the seventh vaccine granted emergency use in the Philippines. The national government has contracted the company to supply 20 million doses for delivery by mid-2021, and targets to buy its additional booster shots.

Novavax

Novavax is a US-based biotechnology company that specializes in vaccine development to combat serious infectious diseases. In its pipeline are vaccine candidates for protection against seasonal influenza, Ebola Virus, Respiratory Syncytial Virus (RSV), MERS, and SARS.

Throughout Novavax’s 34-year run, it has not successfully launched a vaccine product in the market. Failed late stage trials of the RSV vaccine in 2016 even led to monumental loss of shares for the company.

But the small biotech firm has geared up for the development of its own coronavirus vaccine called NVX-CoV2373, which has been found to be effective in preventing severe illnesses and deaths caused by the original COVID-19 virus, as well as variants in the United Kingdom and South Africa. 

Last March, the Philippine government signed a deal with Novavax for 30 million doses of the coronavirus shots through the Serum Institute of India (SII), the world’s largest vaccine manufacturer and Novavax’s partner. However, due to the overwhelming surge of COVID-19 cases in India, delays in vaccine delivery are expected. Because of this, the Philippines reduced its vaccination target from 70 to 90 million people to 50 to 70 million.

The Philippine Food and Drug Administration (FDA) is yet to give Covovax, SII’s version of the COVID-19 vaccine, an EUA. It is projected to arrive in the latter half of 2021. 

Sinopharm

The state-owned China National Pharmaceutical Group Co. Ltd. or Sinopharm is a healthcare titan whose experience in developing and producing medical drugs, devices, equipment, and networks across the globe spans 23 years.

Some scandals that the company was involved in recent years include the 2013 corruption allegations against its former executives and the 2018 allegations about defective combined vaccines for diptheria, tetanus, and whooping cough by its subsidiary company, the Wuhan Institute of Biological Products. 

Given the pandemic, Sinopharm teamed up with its unit, Beijing Institute of Biological Products, to develop a homegrown COVID-19 vaccine, also known as BBIBP-CorV. The company was earlier criticized for being secretive about trial data amid vaccinations in various countries. 

In May, however, the WHO validated the Sinopharm vaccine for emergency use. The firm also published phase 3 trial results, confirming the vaccine’s efficacy without providing enough data on at-risk groups, such as the elderly and persons with comorbidities. 

The Sinopharm vaccine was illegally used by Filipino government officials, employees, and allies when it was administered without regulatory approval in the country as early as September 2020. Among those who received the shot was President Rodrigo Duterte,

On June 7, the Philippine FDA granted the Department of Health an EUA covering the Sinopharm donated to the government.

Vaccine inequity

Given the competitive process for vaccine acquisition and the scarcity of supply in the international market, less developed countries like the Philippines are at a disadvantage. Issues related to patents, technological infrastructure, and manpower also hinder replication of the vaccines in low-income countries.  

This inequity has prompted the establishment of the COVID-19 Vaccines Global Access or COVAX facility, led by the World Health Organization, to help developing nations obtain the vaccines. The Philippines received its first batch of donated Pfizer-BioNTech shots in May, and awaits a fresh batch of deliveries.

Public health practitioner and former health secretary Manuel Dayrit explained that the COVID-19 inoculation drive is unfamiliar space for many since the majority of the past government-wide campaigns had been focused on children and not on adults.

“People compare the numbers between one vaccine and another, [but] it’s actually not the right thing to do. They’re arrived at in different contexts,” he said. 

To increase trust in the mass immunization program, Dayrit believes the government should implement it with full transparency and more information about the vaccines’ efficacy, adverse effects, and risks.

The immense challenge in this approach, however, is communicating factual information to the public given the “super abundance” of sources and channels, along with personal preferences that are also influenced by political beliefs, he said.

“This [pandemic] has been such a traumatic experience…so it’s going to take a while to recover,” he said. “Even as we’re vaccinating, [the trend is] up and down, meaning to say [we] could have surges anytime and they can cause a lot of suffering and death.”

Whether one takes or refuses the coronavirus shots made available to them, Dayrit stressed that necessary behaviors and practices must also be explained for people to avoid being infected or becoming carriers of the virus. This could affect communities at large, especially as scientists have repeatedly warned that COVID-19 won’t be the world’s last pandemic. 

“Many of the viruses that all came up, [they’re from] animal reservoirs. They’re all of animal origin. And as we degrade the environment and we have more contact with animals, these viruses are going to emerge,” Dayrit said. 

Calls for a genuine investigation into COVID-19’s origins are ongoing. The Wall Street Journal reported on new intelligence data suggesting that the virus may have come from a laboratory in Wuhan, China. Resolving this issue, he said, will be crucial in preparing for the next plague. – Rappler.com 

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