J&J pulls its plan for a speedy nod
BENGALURU: Johnson & Johnson said on Monday it was still in talks with the Indian government over its Covid-19 vaccine after the country’s drug regulator announced the company has pulled its proposal seeking an accelerated approval for local trials.
India, in May, scrapped local trials for “well-established” foreign coronavirus vaccines as it tried to hasten vaccination rollouts to fight a devastating second wave of infections.
“We are in ongoing discussions with the Government of India and are exploring how best to accelerate our ability to deliver our COVID-19 vaccine to India,” Johnson & Johnson said in a statement.
Johnson & Johnson is yet to request a full approval for its shot with the U.S. Food and Drug Administration, while Pfizer Inc and partner BioNTech SE, and Moderna Inc have already sought full approval of their vaccines.
In India, the drug regulator gave emergency use authorisation to Moderna’s vaccine in June. As of July 28, only 10% of India’s adult population of about 944 million people had been inoculated with both doses, with 47% receiving at least one shot.
PATNA: Bihar may fail to absorb the 25% share of Covid-19 vaccines, to be routed through the private health care channel, as most of the hospitals are wary of applying afresh for vaccines after a failed attempt in June.
Critical of the Centre repeatedly changing its vaccine allotment policy, most private players have adopted a wait and watch policy, which could affect Bihar’s vaccination drive.
“We are waiting for clarity from the government before we apply afresh. We cannot apply unless the government advises us,” said Dr LB Singh, medical superintendent of the Mahavir Cancer Sansthan (MCS), run by the Mahavir temple trust in Patna.
The cancer hospital had ordered 100 doses of Covishield through the National Health Authority (NHA) in June, but never got them. The NHA refunded ₹63,000 on July 20 against the stock it had applied for on June 29.
Its sister concern, the Mahavir Vatsalya Aspatal, a super-specialty hospital for children, has got neither the vaccines nor the refund after paying upfront for 100 doses of Covishield in June.
“We have communicated to the NHA about non-receipt of vaccines and refund. It has assured us to refund ₹63,000 soon,” said Dr Upendra Prasad Sinha, nodal officer for Covid-19 vaccination at the child hospital.
Dr Sidharth of the KP Sinha Memorial Hospital was also unsure of placing fresh orders after getting a refund.
Urologist Dr Satyajit Kumar Singh, managing director of the NABH-accredited Ruban Memorial Hospital, was critical of the government frequently changing its policy, but had reapplied for the vaccines, as he said there was demand at his hospital.
“The government initially supplied us the vaccines free of cost between January and April. In May, it asked us to purchase the vaccines through them. Now, they want us to buy them directly through the manufacturers. The frequent change in policy is delaying the whole exercise and causing an impediment in the vaccination drive,” said Dr Singh.
A couple of days back, the Ruban hospital paid ₹30 lakh to the manufacturers, but is yet to hear from them about the supply of vaccines.
As per the government’s revised policy, private facilities now have to procure vaccines directly from the manufacturers by paying them in advance. Till June, the government wanted them to route it through its NHA portal, after having supplied the vaccines free between January and April.
Ten private centres, which applied through the NHA, did not get any vaccine in July.
That left Bihar short of its scheduled allocation of vaccines, as it received 86,86,400 doses against an allotment of 91,81,930 for July. Most of these centres have not applies for vaccines again.
The 86,86,400 doses of vaccines the state received last month was against 68,86,450 doses allocated by the Centre for being administered through government facilities.
“We hardly received any vaccine against the 22,95,480 doses allocated through private channel, as per the vaccine supply schedule communicated to us early last month,” said an officer overseeing the vaccination programme in the state.
“Private facilities are wary of applying for vaccines and blocking their money as they are unsure of the demand, especially when the government is administering the vaccines free of cost at its centres, while private players are charging beneficiaries for the service,” said another government officer, requesting anonymity.
The government has capped the maximum per dose price at Rs 780 for Covishield, Rs 1,410 for Covaxin and Rs 1,145 for Suptnik V at private centres.
The BIG Apollo Spectra, Paras-HMRI and Jai Prabha Medanta are the only three among 76 private facilities empanelled with the state government for Covid-19 vaccination that are presently engaged in the vaccination programme. They are, however, getting the vaccines through their corporate offices outside the state.
Bihar has set a target to inoculate its 7.22 crore target population by December 31 but had administered only 2.48 crore doses so far.