Brazilian officials said Thursday that a coronavirus vaccine made by a Chinese company was effective, bolstering the chances of approval for a second Chinese inoculation that could be rolled out in much of the developing world.
Officials in the state of São Paulo, where a prominent medical research institute carried out a large study of the vaccine made by the Beijing-based Sinovac, said the inoculation had an efficacy rate of 78 percent.
The vaccine prevented all participants from developing serious and mild complications from the virus, officials said, calling it a highly effective preventive tool.
In anticipation of approval, the vaccine, called CoronaVac, has already been shipped around the world as countries prepare for mass inoculation campaigns. Sinovac has sold more than 300 million doses, mostly to low- and middle-income countries, accounting for about half of the total doses that China says vaccine makers were capable of producing in 2020, based on an analysis of company statements and media reports.
China has set its sights on supplying the developing world with a Covid-19 vaccine, in a push to position itself as a leader in health diplomacy after its failures in the early days of the outbreak. It also wants to burnish its credentials in science by becoming a major player in the global vaccine business.
Even without the regulatory greenlight, China has embarked on an aggressive vaccination drive at home, with the goal of inoculating 50 million people by the middle of next month. Beijing has also developed an overseas distribution plan for exports, directing airlines to stock up on refrigerators and dry ice.
China is filling a void in poorer nations left by Western competitors. The United States is mainly focused on working through the chaos of distributing its vaccines at home. The European Union and other rich countries have bought many of the doses supplied by the American drugmakers Pfizer and Moderna.
“The Chinese have been eager to get out in front, aware of the gap and the hoarding and pre-purchase of so many billions of doses by the Western governments that is leaving so many countries high and dry,” said J. Stephen Morrison, director of the global health policy center at the Center for Strategic and International Studies.
“It will become a tool in their diplomatic alliances, and it will give them some measure of prestige and standing with countries that choose to make use of them,” he added.
Unlike players from the United States, Chinese vaccine makers had to think globally almost from the start. The companies had to go abroad to test for the efficacy of its vaccine because the outbreak had been largely stamped out in China.
In recent months, Chinese companies have signed agreements with at least 15 countries and regions, providing early access to doses. Their vaccines have been rolled out in the United Arab Emirates and Bahrain after being approved for emergency use.
Many of their early customers were the governments that cooperated on the late-stage, Phase 3 trials. Brazil has roughly 10.8 million doses of the vaccine on hand and intends to start producing it locally, and Indonesia and Turkey have both received shipments of Sinovac vaccines. Sinovac has said it is able to produce 600 million doses this year.
These deals could help vaccine makers shake off the industry’s tarnished reputation following a series of quality and corruption scandals. For decades, Chinese vaccine makers focused only on serving its domestic market. Only five Chinese vaccines have been preapproved for export by the World Health Organization — one of them is a hepatitis A shot made by Sinovac.
The results in Brazil are closely watched by regulators in other countries that are conducting trials for the Sinovac vaccine because it had the biggest number of volunteers, at 12,476. Turkey announced on Dec. 24 that the vaccine had an efficacy rate of 91.25 percent but it was based on preliminary results from a small clinical trial. The scientists who ran the trial discussed the results at a news conference, but they did not provide the data online in written form.
The Chinese government said on Dec. 31 that it had approved another coronavirus vaccine made by the state-owned company Sinopharm, which had announced that its Phase 3 trials showed that its vaccine had an efficacy rate of 79.34 percent, but it did not provide any further data from their trial, making it impossible for outside experts to evaluate the claim.
Like the Sinopharm vaccine, CoronaVac is made with a traditional technology that uses an inactivated virus to provoke the body’s immune system to produce antibodies.
With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:
- If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
- When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
- If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This appears to be enough protection to keep the vaccinated person from getting ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose — and be sneezed or breathed out to infect others — even as antibodies elsewhere in the body have mobilized to prevent the vaccinated person from getting sick. The vaccine clinical trials were designed to determine whether vaccinated people are protected from illness — not to find out whether they could still spread the coronavirus. Based on studies of flu vaccine and even patients infected with Covid-19, researchers have reason to be hopeful that vaccinated people won’t spread the virus, but more research is needed. In the meantime, everyone — even vaccinated people — will need to think of themselves as possible silent spreaders and keep wearing a mask. Read more here.
- Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain. While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine that will provide long-lasting immunity.
- Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.
These vaccines tend to have weaker efficacy rates, but they can be kept at refrigerated temperatures, making transportation and storage easier. Such characteristics are especially important for developing countries that may not have the infrastructure to maintain the frozen vaccines made by Pfizer and Moderna. Sinovac’s chief executive, Yin Weidong, called the inactivated technology “the best” one for the vaccine.
Even before the pandemic, Sinovac’s reputation was well established within the biotech world. In 2003, it was the first company in the world to develop an experimental vaccine for another coronavirus outbreak — severe acute respiratory syndrome, or SARS.
The company started testing it on humans but had to scrap further trials after the outbreak ended. But the experience proved fortuitous.
Sinovac began work on a Covid-19 vaccine soon after a top Chinese epidemiologist disclosed on national television in late January that the coronavirus in Wuhan was being transmitted between humans. Scientists at the company canceled their Lunar New Year vacations and set to work on Operation Coronavirus.
Mr. Yin, 56, started his career as a doctor at the local disease and control center in the northern city of Tangshan. He was troubled by the scourge of hepatitis A and began wondering how he could make a vaccine to curb the disease.
In 1985, Mr. Yin, then 21, was the first to isolate the hepatitis A virus, and in 2001, he founded Sinovac Biotech.
Along the way, Sinovac has been caught up in the industry’s bad practices. From 2002 to 2011, Mr. Yin paid $77,000 to a senior Chinese drug regulator, Yin Hongzhang, and his wife to approve his vaccines, according to a 2018 filing to the Securities and Exchange Commission, citing court documents.
The regulator was jailed in 2017 for taking bribes from company executives, including the head of another vaccine company that has joined forces with AstraZeneca to make a Covid-19 vaccine. The executives did not face scrutiny.
A Sinovac spokesman, Pearson Liu, said that the incidents happened more than 10 years ago, adding that “neither Mr. Yin nor the company have been accused of any wrongdoing by any government authority on the allegations.”
Sinovac’s key shareholders tried to use the bribery case involving Mr. Yin to oust him from his company. The messy battle culminated in the firm’s electricity supply being cut off by representatives of a key shareholder and a temporary halt to the supply of hepatitis A vaccines in China.
Through it all, Mr. Yin has emerged unscathed, creating a corporate front-runner in China’s Covid-19 vaccine outreach efforts.
After promising early-stage trials, Sinovac determined that it would need help from a research institute in a place with an active outbreak. Brazil has the third-highest number of Covid-19 infections in the world after the United States, at 7.8 million cases, allowing Sinovac to test much faster for the efficacy of its vaccine.
Brazil’s Instituto Butantan looked like an ideal partner. Both companies had developed a relationship that had started before the pandemic, according to Dimas Tadeu Covas, director of Instituto Butantan. The institute was also well versed in the technology that Sinovac was using.
“We had common interests, and especially, the capacity to do this very quickly,” Mr. Covas said in an interview.
In going abroad, Sinovac has been forced to navigate political minefields.
The company’s website was defaced by hackers from Turkey in recent weeks. The hackers put up the flag of East Turkestan, an emblem banned in China and generally used as a symbol of independence for the Uighurs, a Turkic Muslim minority group.
Its clinical trial has been criticized by supporters of President Jair Bolsonaro, who has rejected his health ministry’s plan to purchase 46 million doses. In November, the trial was briefly suspended after the death of a participant, a regulatory move that Mr. Bolsonaro — who has blamed China for the pandemic — hailed as a victory. The trial was resumed after the health authority ruled that the death had been unrelated to the vaccine.
It is unclear whether the Sinovac vaccines will even be used throughout Brazil. João Doria, a rival of Mr. Bolsonaro’s and the governor of the state of São Paulo, which has run the trials for Sinovac, has negotiated directly with the Chinese company for vaccine doses. He has announced that his state intends to start vaccinating people in late January, subject to regulatory approval. It’s the only state in the country to buy the Sinovac vaccine.
“Today is a very important day for Brazil, for Brazilians, for life and for health,” Mr. Doria said on Thursday at a news conference, standing behind a podium marked with the hashtag #VaccineNow.
Mariana Simões contributed reporting. Elsie Chen contributed research.