Vaccine updates: What you need to know about vaccine trials, production

90% of China’s Sinovac employees, families took coronavirus vaccine: CEO

BEIJING: About 90% of Sinovac Biotech Ltd employees and their families have taken an experimental coronavirus vaccine developed by the Chinese firm under the country’s emergency use programme, its chief executive said on Sunday.

The extent of inoculations under the emergency programme, which China launched in July but has released few details about, points to how actively it is using experimental vaccines in the hopes of protecting essential workers against a potential COVID-19 resurgence, even as trials are still underway.

The programme is intended for specific groups, including medical staffers and those who work at food markets and in the transportation and service sectors.

Sinovac, whose CoronaVac is in Phase 3 clinical trials and has been included in the emergency scheme, offered the candidate vaccine to approximately 2,000 to 3,000 employees and their families on a voluntary basis, CEO Yin Weidong told Reuters.

Data gathered from the programme could offer evidence of the vaccine’s safety, but such data, which is not part of the registered clinical trial protocols, will not be used as main materials that regulators review in judging whether to approve the vaccine for commercial use, Yin said.

He said those who chose to be inoculated, including his wife and parents, had been informed of the potential side effects prior to taking the shot, and that its vaccine completing only early and mid-stage trials.

Yin, who also took the shot, said doctors asked about their health conditions before the vaccination, and the occurrence rate of adverse reaction among those vaccinated has been “very low”.

Side effects after taking CoronaVac include fatigue, fever and pain, with mostly mild symptoms, according to results of a mid-stage trial sponsored by Sinovac, involving 600 participants and published last month ahead of peer review. No vaccine has passed final, large-scale trials to prove it is effective and safe enough to protect people against the virus that has led to over 870,000 deaths globally. – Reuters

Russia vaccine ‘passes early trial test’

LONDON: Patients involved in early tests of a Russian coronavirus vaccine developed antibodies with “no serious adverse events”, according to research published in The Lancet Friday, but experts said the trials were too small to prove safety and effectiveness.

Russia announced last month that its vaccine, named “Sputnik V” after the Soviet-era satellite that was the first launched into space in 1957, had already received approval.

This raised concerns among Western scientists over a lack of safety data, with some warning that moving too quickly on a vaccine could be dangerous.

Russia denounced criticism as an attempt to undermine Moscow’s research. In the Lancet study, Russian researchers reported on two small trials, each involving 38 healthy adults aged between 18 and 60, who were given a two-part immunisation.

Each participant was given a dose of the first part of the vaccine and then given a booster with the second part 21 days later. They were monitored over 42 days and all developed antibodies within the first three weeks.

The report said the data showed that the vaccine was “safe, well tolerated, and does not cause serious adverse events in healthy adult volunteers”.

The trials were open label and not randomised, meaning there was no placebo and the participants knew they were receiving the vaccine and were not randomly assigned to different treatment groups.

Researchers underlined that larger and longer trials – including a placebo comparison – would be needed to establish the long-term safety and effectiveness of the vaccine for preventing Covid-19 infection.

The report said the 76 participants of these trials would be monitored up to 180 days, adding that a more rigorous phase 3 clinical trial was planned with the involvement of 40,000 volunteers “from different age and risk groups”.

Russian study encouraging, but small

Naor Bar-Zeev of Johns Hopkins Bloomberg School of Public Health, who was not involved in the study, said the research was “encouraging but small”, adding that it did not give any data on effectiveness among older age groups, who are particularly vulnerable to Covid-19.

“Showing safety will be crucial with COVID-19 vaccines, not only for vaccine acceptance but also for trust in vaccination broadly,” he said in a commentary in the Lancet.

“Since vaccines are given to healthy people and, during the COVID-19 pandemic, potentially to everyone after approval following phase 3 trials, safety is paramount.”

Russia has said that industrial production of its version is expected from September. President Vladimir Putin said in early August that the vaccine gave “sustainable immunity” and that one of his own daughters had been inoculated, even though Russia’s health ministry said clinical trials were not yet complete.

The World Health Organization has urged Russia to follow established guidelines and go “through all the stages” necessary to develop a safe vaccine.

It uses a cold-causing adenovirus, which is then modified and combined with a part of the new coronavirus, SARS-CoV-2.

The report’s lead author, Denis Logunov of Gamaleya, said the adenovirus vaccine enters people’s cells and delivers the SARS-CoV-2 spike protein genetic code, helping the immune system “recognise and attack” the virus. – AFP

Australia to receive first batch of AstraZeneca COVID-19 vaccine in Jan 2021

SYDNEY (Reuters): Australia will receive the first doses of an AstraZeneca and Oxford University COVID-19 vaccine in January 2021 if trials prove successful, after Canberra agreed a deal to purchase a second potential vaccine, Prime Minister Scott Morrison will say on Tuesday.

Australia said in August it had signed a preliminary agreement with AstraZeneca for enough doses for its population of nearly 26 million, which would be manufactured locally by pharmaceutical company CSL.

That deal appeared in some doubt when CSL said its priority was manufacturing an alternative potential vaccine developed with the University of Queensland (UQ).

Agreeing a deal to overcome the potential roadblock, Australia will now also buy 51 million doses of the UQ vaccine.

It will take possession of the first 3.8 million doses of the AstraZeneca vaccine in January and February 2021, and then receive a further 30 million doses, Morrison will say in extracts from an announcement sent to Reuters.

AstraZeneca’s candidate is seen as a frontrunner in a global race to deliver an effective coronavirus vaccine.

Under the deal with UQ and CSL, Australia will buy 51 million doses of that tie-up’s vaccine. The UQ and CSL candidate is scheduled to begin phase two trials in late 2020 and if all trials are successful it could be rolled out to Australians in mid-2021.

Both deals will cost in total A$1.7 billion ($1.24 billion), Morrison will say. Should both vaccines prove successful, Australia has secured to right to donate or sell on without a mark-up.

Health officials are discussing who will receive the first doses if trials are successful, Morrison will say. Vulnerable people, and front-line health care workers likely to be first in line, a source familiar with the details told Reuters.

UN President: “Inclusion is key” for vaccine

UNITED NATIONS: The president of the United Nations General Assembly is warning that a vaccine for COVID-19 must be made available to everyone who needs it because if just one country is left out the world will still face a crisis from the coronavirus.

As the world looks to a vaccine and a post-COVID-19 world, Tijjani Muhammad-Bande also warned that “inclusion is key, because without inclusion the suffering of those who are already left behind, will continue — and we cannot guarantee peace in that kind of a context.”

He said statements from those developing vaccines have said they intend to make them widely available which is important. “I believe that there will be protocols and agreements to guarantee affordability and accessibility to the product when it is available,” he said.

Muhammad-Bande said in an interview Thursday with The Associated Press that the pandemic, perhaps ironically, has defied initial predictions that developing countries would be hardest hit because many of their health systems are poorer.

But what has happened, he said, is that death rates and infections are far lower in percentage terms in developing countries, including in Africa, than in the major developed countries of the world.

Muhammad-Banda, who is also Nigeria’s ambassador to the United Nations, said richer developed countries were able to give more support to their citizens during the pandemic than developing countries, including health insurance and financial support, which put a spotlight on inequalities in the world.

“One vaccine isn’t enough”: Mexico aims for its own coronavirus fix

MEXICO CITY: Mexico is working to produce its own COVID-19 vaccines and could have one ready by next spring, according to a researcher coordinating local efforts amid a global race to tame a disease that has infected over 26.75 million people worldwide.

Esther Orozco, coordinator of the scientific group that represents Mexico at the Coalition for Epidemic Preparedness Innovations, said research based on a virus that transmits the avian Newcastle disease is the most viable candidate to produce the first vaccine in Mexico.

Orozco said the vaccine, developed by the private firm Laboratorio Avimex with researchers from Mexico’s main public university, UNAM, and the Mexican Social Security Institute, is ready to start the first phase of testing with humans.

“They are advanced,” Orozco told Reuters in an interview. “I think it’s going to be ready by spring or the start of summer.” She said the Avimex vaccine trials will begin with “dozens of humans.” A second stage will see “hundreds of patients” before thousands of volunteers take part in final Phase 3 studies.

Avimex, normally dedicated to the manufacture of vaccines and pharmaceutical products for animals, did not respond to a request for comment.

Mexico has launched a global effort to build diplomatic and commercial alliances to ensure it receives the approximately 200 million vaccine doses it estimates it will need for a disease that has infected more than 623,000 people and killed at least 66,851 in Latin America’s second-largest economy.

Vaccine safety key to UN endorsement 

LONDON: The head of the World Health Organization says the U.N. health agency won’t recommend any coronavirus vaccine before it is proved safe and effective.

Tedros Adhanom Ghebreyesus made the comment Friday, even as Russia and China have started using their experimental vaccines before long-term studies have been completed. Other countries have proposed streamlining authorization procedures.

He says vaccines have been used successfully for decades and credited them with eradicating smallpox and bringing polio to near elimination. He pointed to newly developed Ebola vaccines that helped end the recent Ebola outbreak in Congo.

Tedros appealed to people opposed to vaccination to do their own research.

“The anti-vaccine movement, they can build narratives to fight against vaccines. But the track record of vaccines tells its own story and people should not be confused,” he says. “They can have a look for themselves on how the world actually used vaccines to reduce under 5 mortality to save children.”

He says he’s hopeful there’d soon be an effective coronavirus vaccine “so the world can get back to normal.”

$11.80 for Sanofi vaccine

PARIS: A coronavirus vaccine that Sanofi is developing with Britain’s GlaxoSmithKline is likely to be priced at less than 10 euros ($11.80) per shot if it is approved for use, Sanofi’s chief in France said on Saturday.

“The price is not totally set … We are assessing production costs for the coming months … We will be below 10 euros,” Olivier Bogillot told France Inter radio.

Drugmakers and government agencies are racing to come up with vaccines for the new coronavirus and treatments for COVID-19, the respiratory diseases it causes which wrecked economies and killed nearly 1 millio.

Asked about rival AstraZeneca, which is expected to price its shot at about 2.50 euros in Europe, Bogillot said: “The price gap for us can be that we use all our internal resources, our own researchers, our own research centres.

AstraZeneca outsources part of its production.” A Sanofi spokeswoman said in an emailed statement on Sunday that a final price would only be decided when the vaccine reaches its final testing stage.

If the results are positive, Sanofi and GSK hope to get the vaccine approved in the first half of next year.

Brazil’s Tecpar to test Russian vaccine on 10,000 people in early 2021

BRASILIA: The technology institute for the Brazilian state of Parana’s, which has signed an agreement to produce Russia’s Sputnik V coronavirus vaccine, said on Friday it plans to conduct phase III trials on 10,000 volunteers in Brazil at the start of next year.

Jorge Callado, head of Parana’s Technology Institute, known as Tecpar, said approval for the trial will be requested of Brazil’s health regulator ANVISA by the end of this month. Doses will be imported for the tests and Tecpar plans to produce the vaccine for Brazil’s market in the second half of 2021, he said.

50,000 people taking part in phase 3 trial of Chinese COVID-19 Vaccine

BEIJING: Around 50,000 people in a number of countries are participating in phase 3 clinical trials of a coronavirus vaccine developed by the China National Biotec Group (CNBG), the company said on Saturday in a press release.

“The third phase of clinical trials of the inactivated CNBG vaccine against COVID-19 is significantly accelerating, and clinical trials are already underway in several countries, including Bahrain, UAE, Morocco, Peru, Argentina, with about 50,000 people participating,” the CNGB said.

Media reported in July that phase 3 trial of CNBG’s vaccine would also be also held in Uzbekistan, and Pakistan has expressed interest in holding clinical trials as well.

Coronavirus vaccine candidates offered to aviation industry workers

BEIJING: China has offered experimental coronavirus vaccines to aviation industry workers, according to a regulatory notice seen by Reuters, in a push to inoculate high-risk groups to prevent a possible resurgence as economies reopen.

China, which has four COVID-19 vaccines in the final stage of human trials, launched the emergency use vaccine programme in July, hoping to boost the immunity of groups such as border inspectors or medical industry workers.

Frontline workers at Chinese airlines, airports, China National Aviation Fuel Group and TravelSky Technology Limited will be provided a candidate vaccine on a voluntary basis, the notice from China’s aviation regulator shows.

The Civil Aviation Administration of China has asked these sectors and firms to compile a list of personal information of employees willing to take the vaccine, the notice adds.

The vaccination is “in response to a possible second wave of infections erupting in the fall and winter, and to the huge pressure facing our work of preventing imported cases as western countries reopen despite the pandemic”, according to the notice.

While the regulator did not immediately respond to a Reuters request for comment, several staffers at Air China, China Southern Airlines and Juneyao Airlines confirmed they had received such a notice.

Juneyao said it had submitted a list of employees willing to take the vaccine. The other airlines did not immediately reply to requests for comments.

It is not clear yet which candidate vaccine will be given and how many people will be vaccinated.

At least two experimental vaccines, one from Sinovac Biotech Ltd and the other from China National Biotec Group, have been approved for emergency use in China.

No vaccine has yet passed final, large-scale trials to prove it is effective enough to protect people from contracting the virus that has led to over 860,000 deaths globally.

Africa-CDC says all countries should join global COVID-19 vaccine effort

NAIROBI: All countries should join hands in a global effort to procure and distribute potential vaccines against the coronavirus across the globe, the head of the Africa Centres for Disease Control and Prevention said on Thursday.

“We are in this together. No country will be safe if any other country in the world still has cases of COVID,” John Nkengasong, the head of the Addis Ababa-based continental body, told an online news conference.

He was reacting to reports of a decision by the United States to shun the global initiative due to the involvement of the World Health Organisation.

AstraZeneca’s COVID-19 vaccine candidate enters late-stage study in U.S.

AstraZeneca Plc said on Monday it began to enroll 30,000 participants aged above 18 in a late-stage study to evaluate its COVID-19 vaccine candidate, AZD1222.

Participants are being randomized to receive two doses of either AZD1222 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine as the saline control, the company said. The study is being funded by the U.S. government, the London-listed company said.

Supply tie-up with Oxford Biomedica

AstraZeneca has expanded its agreement with Oxford Biomedica to make and supply the drugmaker’s COVID-19 vaccine candidate, in a deal that will pay the gene and cell therapy firm $15 million upfront and an additional $35 million plus other costs by the end of 2021.

Oxford Biomedica said in a statement that under the deal, it would mass-produce the potential vaccine, AZD1222, for the novel coronavirus for a period of 18 months, which may be further extended by another 18 months into 2022 and 2023.

Deal with Albany Molecular to produce COVID-19 vaccine candidate

AstraZeneca Plc on Thursday signed a manufacturing deal with privately held Albany Molecular Research Inc to produce millions of doses of the British drugmaker’s experimental coronavirus vaccine annually.

The contract drug manufacturer and research company said the agreeement will help bolster supply of the vaccine through sterile finishing services at its manufacturing plant in Albuquerque, New Mexico.

Albany Molecuar did not disclose the terms of the deal, while AstraZeneca did not immediately respond to a request for comment.

AstraZeneca has been scaling up production of the vaccine candidate, mainly through deals such as its expanded agreement with cell therapy firm Oxford Biomedica to mass-produce its COVID-19 vaccine candidate. Albany Molecular in 2017 agreed to be taken private by buyout firms Carlyle Group and GTCR LLC for about $922 million in cash.

Australia will buy 51 million doses of that tie-up’s vaccine. The UQ and CSL candidate is scheduled to begin phase two trials in late 2020 and if all trials are successful it could be rolled out to Australians in mid-2021.

Both deals will cost in total A$1.7 billion ($1.24 billion). Should both vaccines prove successful, Australia has secured to right to donate or sell on without a mark-up.

Vulnerable people, and front-line health care workers likely to be first in line, a source familiar with the details told Reuters.

The supply agreements come as Australia grapples with a second wave of infections in its second most populous state, Victoria. Australia has recorded more than 26,000 infections and 753 deaths.

Russia in talks with India for production of Sputnik-V vaccine 

New Delhi: Russia is in close dialogue with the Indian government and the leading drug manufactures of India regarding the localisation of production of Sputnik V vaccine in India, said Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF) on Friday.

On August 11, the Sputnik V vaccine developed jointly by RDIF and the Gamaleya National Research Center of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19.

According to Russian researchers, Sputnik V is a human adenoviral vector vaccine which fights against coronavirus disease.

“India has historically been a very important partner of Russia. India is one of the leading countries in production. Around 60 percent of all the vaccines in the world are produced in India. We are in close dialogue with the corresponding ministries and the India government and the leading manufacturer of the country regarding localisation of production of Sputnik V vaccine in India. And we have achieved certain agreements with the leading companies,” Dmitriev said in response to an ANI query on the current talks between India and the Russian government on Sputnik V vaccine.

“We do recognise India and it’s potential to become one of the support for the production of the vaccine not only in Indian markets but for other countries too. We very much appreciate the well- balanced approach expressed by the Indian partners as from the very beginning they started asking questions how our vaccine works and we appreciate it that they did not try to attack our vaccine but try to understand it,” Dmitriev adding that their (India’s) desire to understand our vaccine got to realize that their approach based on the human adenoviral vaccine platform is the most reasonable approach.

Brazil leader rapped for stirring doubt on COVID-19 vaccine

Critics of Brazil’s President Jair Bolsonaro are again speaking out against the leader’s stance on the coronavirus pandemic, this time rejecting his view that vaccination for the virus shouldn’t be mandatory

SAO PAULO (AP): Critics of Brazilian President Jair Bolsonaro are again speaking out against the leader’s stance on the coronavirus pandemic, this time rejecting his view that vaccination for the virus shouldn’t be mandatory.

Bolsonaro’s first such comments came Monday, when he told a supporter, “No one can force anyone to get a vaccine.” He repeated it Thursday night during a live broadcast on Facebook, adding his opposition to administering vaccines that are yet to be proven on Brazilian soil.

“It has been proven in other countries, but not here in Brazil,” he said, without specifying to which potential vaccine he was referring. “We cannot be irresponsible and put a vaccine into people’s bodies. As I said, nobody can oblige someone to take a vacccine.”