Covid-19: Race for Indian vaccine hots up, human trials on in 6 cities
NEW DELHI: The race for an indigenous vaccine against the novel coronavirus is on in earnest. Human trials using the vaccine candidates of two companies — Bharat Biotech and Zydus Cadila — are currently on in six cities in as many states. The latest subject was a 30-year-old man who on Friday was the first person from Delhi to be given a 0.5 ml intramuscular injection of Bharat Biotech (BB)’s Covaxin at AIIMS.
新德里消息：印度本土新冠病毒疫苗竞赛正在激烈进行。目前，Bharat Biotech和Zydus Cadila这两家公司的候选疫苗正在六个城市进行人体试验。最新的受试者是一名30岁的男子，他于上周五在全印度医学研究院肌肉注射了0.5 ml Bharat Biotech公司(BB)的Covaxin疫苗。
Both BB and Zydus were granted permission for Phase I and II clinical trials and administered the first doses of their vaccine candidates to volunteers on July 15.
A third vaccine candidate, developed by Oxford University, is soon to be tested in India. Serum Institute, which is in a manufacturing partnership with the UK’s Astra Zeneca, has said it will begin human trials as soon as it receives regulatory approval.
BB’s Covaxin, developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), will be tested at 12 hospitals — including AIIMS, Delhi and Patna, and PGI Rohtak — in 12 cities. The first phase will involve over 500 volunteers, all healthy and between the ages of 18 and 55 with no co-morbidities.
Testing of Zydus’s candidate, ZyCoV-D, is currently limited to its research centre in Ahmedabad, but will be extended to multiple cities.
Covaxin trials have already begun in Hyderabad, Patna, Kancheepuram, Rohtak, and now Delhi, to be followed by Nagpur, Bhubaneshwar, Belgaum, Gorakhpur, Kanpur, Goa and Visakhapatnam.
At AIIMS, Delhi, Dr Sanjay Rai, principal investigation of the vaccine trial project, told TOI, “We observed him (the 30-year-old subject) for two hours. There was no immediate side-effect.” He said the volunteer has been allowed to go home for now and he will be examined again after two days.
AIIMS Patna, which started human trials of Covaxin on 11 volunteers on July 15, has not encountered any major side-effects in volunteers. The results of the first dose are yet to come in.
“There are some minor side effects – like redness of skin where the dose was given, pain and mild fever – which can be seen in any vaccine test. But it went smoothly without any other health issues. The doctors are continuously monitoring their health,” said AIIMS-Patna director P K Singh, who’s heading the human trials. “The second dose will be given on July 29, after we’ll run some tests to make sure that the first dose had no side-effect. We will see how much antibodies developed,” he said, adding that 18 persons have been shortlisted for the trial and only seven more people are left for the first dose, “which we will complete in the next few days”.
“有一些小的副作用，比如注射部位的皮肤发红、疼痛和轻微发热，这些症状在任何疫苗试验中都可能出现。但一切进展顺利，没有出现任何其他健康问题。医生们一直在监测他们的健康状况，”AIIMS-Patna主任P K Singh说道，他负责人体试验。“第二剂将在7月29日注射，之后我们会进行一些测试以确保第一剂没有副作用。已经有18人入围了这次试验的候选名单，还剩7人将接受第一剂疫苗，我们将在未来几天内完成这项工作，”他补充道。
The Post-Graduate Institute of Medical Sciences (PGIMS) in Rohtak has readied 20 volunteers and administered the first dose to three people on July 17. State nodal officer Dhruva Chaudhary said Rohtak’s PGIMS and Patna's AIIMS have enrolled 20 subjects each so far. “None of the 20 volunteers showed any adverse impact of the vaccine. We are planning to start the second phase of human trials soon,” he added. Dr Savita Verma, the trial’s principal investigator at the institute, said the first batch is to be given a second dose on July 31.
Human trials at SRM Medical College Hospital and Research Centre in Kancheepuram, near Chennai, began on Thursday with two volunteers being administered 0.05 ml of the vaccine each. They will get the next dose on day 14. The volunteers will have to visit the hospital for follow-ups on days 28, 42, 104 and 194 when their response to the vaccination will be assessed by immunogenicity testing.
Hats off to the Indian pharmaceutical industry for taking up the challenge and soon provide a vaccine
Let's hope that the 'Made in India' vaccine becomes a success and spread all over the world.
Hope somebody develops the vaccine, if it’s India, we must be all proud and cured first.
It seems India will be the first country to produce Covid vaccine for all. Jai vigyan! Jai vigyanik! Jai Bharat!
Our best wishes to Bharat Biotech and Zydus for starting vaccine trails on on the patients and hope best results would come out