UPDATE - Oxford COVID-19 vaccine halted, trial ongoing in India

UPDATES WITH NOTICE BY INDIA'S DRUG REGULATOR; ADDS DETAILS

By Ahmad Adil

NEW DELHI, India (AA) - Trials of the COVID-19 vaccine manufactured jointly by the British drug manufacturer AstraZeneca and Oxford University are ongoing in India, although its trial has been halted by AstraZeneca.

"We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all," said the Serum Institute of India (SII), the firm conducting trials for the COVID-19 vaccine in India, told Anadolu Agency in a brief statement.

On Wednesday evening, India’s central drug regulator served a notice to the SII for not informing it about AstraZeneca pausing the clinical trials of the Oxford vaccine for COVID-19 in other countries and “also for not submitting casualty analysis of the reported serious adverse events", local media reported.

“The Drugs Controller General of India [DCGI], Dr VG Somani, in the notice asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established,” local news agency Press Trust of India said.

Responding the DCGI’s statement, the SII in a statement said: "We are going by DCGI's direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols."

Last month, the country's Drug Controller General of India granted permission to an SII for conducting Phase 2 and three human clinical trials in India for the novel coronavirus vaccine.

On Tuesday, officials said Russia has sought India’s help in the manufacturing of the Sputnik V vaccine by Indian companies and conducting Phase 3 studies in India.

“We are working with this vaccine candidate for manufacturing as well as trial and regulatory facilitation, in the spirit of partnership and science for humanity,” said Dr. Vinod K Paul -- a member of the government's main policy think-tank the National Institute for Transforming India Aayog and also the co-chair of the National Expert Group on Vaccine Administration for COVID-19.

He said several Indian companies have come forward to partner with Russia.

“About four of them have already come forward, the others are in talks with the Russian counterparts and the government is facilitating the process of creating a connection. There may be specific outcomes very soon in that regard,” he said. “This is a win-win situation for India and the world, indeed. India can manufacture that vaccine in large and significant quantities.”

The official website of the Russian vaccine says the Russian Direct Investment Fund sees “strong global interest in the vaccine and plans to conduct Phase 3 clinical trials in different countries, including Saudi Arabia, the UAE, Brazil, and the Philippines, and start mass production in other countries in partnership with local sovereign wealth funds, including India, South Korea, and Brazil, as well as, in Saudi Arabia, Turkey, and Cuba.”

While the prestigious Lancet journal recently published that the Russian vaccine generated a strong immune response and did not produce serious adverse reactions, a group of scientists have alerted Lancet about the vaccine, media reports said.

“The letter by Enrico M. Bucci, an Adjunct Professor at Temple University and well-known for his work in biomedical scientific integrity, along with 15 other scientists from Italy, Japan, Germany, and France, has raised concerns over “potential data inconsistencies” in the published paper,” leading Indian daily The Hindu reported on Wednesday.

The development has come as India continues to witness a massive rise in fresh COVID-19 cases. According to the Health Ministry figures as on Wednesday close to 90,000 new infections were recorded in the country, taking the total number to over 4.3 million.

On Wednesday, the death toll reached 73,890, including 1,115 fresh novel coronavirus-related fatalities in the last 24 hours.

Rana Ayyub, a renowned Indian journalist who is also engaged in relief work, said she tested positive for the virus.

“I have tested positive for COVID-19 after my oxygen levels dipped last night. Have alerted my relief team and all those who have been in touch with me. Still looking for a hospital bed to be admitted in Navi Mumbai,” Ayyub tweeted on Wednesday afternoon.

While India currently ranks second in the number of COVID-19 cases globally, experts in the country say that by the end of September India may even surpass the US -- the worst-affected country worldwide -- in the severity of the pandemic.