India begins human trials of Coviaxin, hoping for Covid-19 vaccine success

Private and state-owned hospitals will test the potential vaccine on volunteers, aged between 18 and 55

Human trials for Covaxin, one of the first potential vaccines developed in India in the fight against Covid-19, is underway in 12 centres across the country.

Covaxin is derived from a strain of the SARS-CoV-2, the virus that causes Covid-19, and it was isolated at the Pune-based National Institute of Virology (NIV).
The Indian Council of Medical Research (ICMR) and Bharat Biotech are jointly working for the preclinical as well as clinical development of this vaccine. It has already received approval for phase-I and phase- II human trials by the Drug Controller General of India (DGCI).

The ICMR had identified 12 clinical trial sites such as medical institutions and hospitals like AIIMS, NIMS, and others.

All India Institute of Medical Science (AIIMS)-Delhi on Monday began recruiting volunteers for conducting human clinical trials of Covaxin, the premier medical institute's director Dr Randeep Guleria said.

He also said that there is not much evidence of community transmission of Covid-19 happening at the national level.

AIIMS-Delhi is among the 12 sites selected by ICMR for conducting Phase I and II randomised, double-blind and placebo-controlled clinical trials of Covaxin.

In phase I, the vaccine would be tested on 375 volunteers and 100 of them, the highest, would be at AIIMS. The second phase, would include around 750 volunteers from all 12 sites put together, Guleria said while addressing reporters.

Phase I of the vaccine trial will be done on healthy people, aged between 18 and 55 years, having no co-morbid conditions. Women with no pregnancy will also be selected to be a part of the trial in the first phase, he said.

Over 400,000 samples tested, 17,615 Indians Covid-19 positive: ICMR

ICMR said that by the end of May it would achieve the testing capacity of 100,000 per day.

The number of total coronavirus (Covid-19) positive cases in India has risen to 17,615 according to the latest data released by the Indian Centre for Medical Research (ICMR).

The release said "Today, on 19 April 2020, till 9 pm, 27,824 samples have been reported. Of these, 1,135 were positive for SARS-CoV-2.

According to ICMR a "total of 4,01,586 samples from 3,83,985 individuals have been tested as on 19 April 2020, till 9 PM. 17,615 individuals have been confirmed positive among suspected cases and contacts of known."

The ICMR will conduct a study to identify the effectiveness of Bacillus Calmette-Guerin (BCG) vaccine against Covid-19, as per the Union Health Ministry officials. It may be noted that it is administered against tuberculosis immediately after the birth of an infant.

ICMR also said that soon it will reach the testing capacity of 100,000. "The daily Covid-19 testing capacity at various laboratories in the country is being increased and is expected to reach to 1 lakh test per day by May 31," it said.

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Accordingly, a total of 16 regional depots are being set up and are modelled into self-contained units by strengthening manpower, resources and infrastructure. Besides these, depots at the National Institute of Malaria Research here and the National Institute of Virology in Pune would also function as central depots.

Union Health Minister Harsh Vardhan on Sunday asserted that doubling rate of Covid-19 cases has increased from three days before imposition of lockdown in March to 9.7 days now.

28,941 samples tested on April 15, says ICMR; WHO lauds health ministry

ICMR has also issued a list of 176 government laboratories and 78 private laboratories for the coronavirus testing.

Continuing its fight against coronavirus, the Indian Council of Medical Research (ICMR) said a total of 2,74,599 samples have been tested for Covid-19 detection so far, with 28,941 samples being tested on Wednesday.

The samples were taken from 2,58,730 individuals which is lower than the samples tested because many suspected patients were tested more than once, according to the statement released by ICMR.

On April 15, till 9 p.m., 28,941 samples have been reported, out of which 953 were found positive for Covid-19.

"At least 11,297 individuals have been confirmed positive among suspected cases and contacts of known positive cases in India," it said.

ICMR has also issued a list of 176 government laboratories and 78 private laboratories for the coronavirus testing.

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Delhi has 8 government labs, including AIIMS, Lady Hardinge Medical College, National Centre for Disease Control, Ram Manohar Lohia Hospital, Institute of Liver & Biliary Sciences, Army Hospital Research & Referral, Maulana Azad Medical College, Vardhman Mahavir Medical College and Safdarjung Hospital.

Other than Delhi, there are 17 in Tamil Nadu and Maharashtra, 15 in Uttar Pradesh, 12 in Karnataka, 10 in Kerala, nine in Madhya Pradesh and Gujarat, eight in Rajasthan, seven in Andhra Pradesh, five in Assam and Bihar among others.

Newborns may get Covid-19 transmission from mothers: ICMR issues guidelines

ICMR pointed out that health care practitioners should immediately create an isolation facility for pregnant mothers with Covid-19 and should follow the national protocol.

According to the Indian Council of Medical Research (ICMR), there is a possibility of transmission of coronavirus from a pregnant mother to a newborn baby. However, the proportion of pregnancies affected and the significance to the newborn is yet to be determined, ICMR said on Monday.

The available scientific evidence suggests that transmission of the virus can happen to a baby before the birth, while it is in the mother's womb, or during delivery from an infected pregnant mother. However, the country's top medical research body added that at present, there are no recorded cases of breast milk being tested positive for Covid-19.

Issuing guidance for the management of pregnant women during the Covid-19 pandemic, ICMR said, "There are reports of Covid-19 pneumonia in pregnancy which are milder and have a good recovery. Also, there are case reports of pre-term birth in women with Covid-19, but it is unclear whether the pre-term birth was always iatrogenic, or whether some were spontaneous."

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"A registry for all women admitted with confirmed Covid-19 infection in pregnancy should be maintained. Maternal and neonatal records including outcome should be completed in detail and preserved for analysis in the future," according to the ICMR.

"With regard to vertical transmission (transmission from mother to baby antenatally or intrapartum), emerging evidence now suggests that vertical transmission is probable, although the proportion of pregnancies affected and the significance to the neonate has yet to be determined."