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Contractor that ruined 15M doses of J&J vaccine is holding up vaccine to India


Funeral pyres of people who died of COVID-19 being prepared simultaneously at Gazipur crematorium on April 26, 2021 in New Delhi, India.
Enlarge / Funeral pyres of people who died of COVID-19 being prepared simultaneously at Gazipur crematorium on April 26, 2021 in New Delhi, India.

India’s skyrocketing surge of COVID-19 cases has launched the country into the most harrowing crisis yet in the pandemic.

While international aid pours into the country, many have called for the US to donate millions of doses from its stockpile of AstraZeneca’s COVID-19 vaccine to India, which has vaccinated less than 2 percent of its population and is running out of doses.

AstraZeneca’s vaccine is widely used around the world, including in India, but it is not yet authorized for use in the US. Even if it does earn authorization here, Biden administration officials say it’s unlikely that the US will need the vaccine, given the healthy quantity of supplies of the three COVID-19 vaccines already authorized in the country made by Moderna, Pfizer-BioNTech, and Johnson & Johnson.

As such, Biden administration officials on Monday said they plan to share 60 million doses of the AstraZeneca vaccine with other countries, including India. But that tally of doses is only expected to become available over the next two months, administration officials said.

Dubious doses

About 10 million AstraZeneca doses already made in the US are ensnared in the problems of Emergent BioSolutions, the contract vaccine manufacturer notorious for ruining 15 million doses of Johnson & Johnson’s COVID-19 vaccine. Emergent is also responsible for making the AstraZeneca vaccine in the US. In fact, Emergent ruined those J&J vaccine doses by contaminating them with elements of AstraZeneca’s vaccine, which the company was making in the same troubled Baltimore facility.

The facility has not yet been authorized by the Food and Drug Administration for vaccine production. And according to a facility inspection report released by the FDA last week, Emergent is unlikely to get that authorization quickly. FDA inspectors logged a slew of significant failings and violations at the plant, including improperly trained staff and ample opportunities for contamination. The inspectors also reported that Emergent failed to thoroughly investigate exactly how millions of doses of the J&J vaccine and AstraZeneca vaccine became contaminated.

As such, “there is no assurance that other batches have not been subject to cross contamination,” the inspectors wrote in their report. That is, the quality of the 10 million AstraZeneca doses the US already has is now in question.

Currently, vaccine production is halted at the plant while Emergent works to fix its mistake. The FDA is also working to confirm that the stockpiled doses of AstraZeneca’s vaccine are fit for use. No doses of AstraZeneca’s vaccine can be shipped out of the US to any other country until they meet the FDA’s quality standards, administration officials said.

Federal lawmakers, meanwhile, are investigating whether Emergent used ties to the Trump administration to unduly earn millions of dollars’ worth of federal grants, despite a long track record of failings and persistent quality-control problems.

In the best-case scenario, the FDA’s quality check is expected to wrap up in the coming weeks. Once that’s complete—if the doses are found to be of high enough quality—the doses can begin to ship out. If all goes well at Emergent’s Baltimore facility, 50 million doses at various stages of production are estimated to be finished in May and June.

The timeline is agonizingly slow to help with India’s current situation.

Country in crisis

On Monday, India reported 352,991 new COVID-19 cases, a world record for the largest number of cases in a single day. It was the fifth straight day the country broke that record. With Tuesday’s total of 323,144 new cases, the country has reported more than 1.7 million new cases in the last five days. And that is likely an undercount due to testing constraints and mild cases that go unreported. About a month ago, the country was seeing around just 40,000 cases a day among its population of about 1.3 billion.

Daily deaths have likewise gone skyward, rising from around 200 a day a month ago to records approaching 3,000 in a single day for the past several days.

The health system is collapsing in many areas. Hospitals in the worst-hit places are overwhelmed and running low on critical supplies such as oxygen. Officials have converted hotels and railway coaches to critical care facilities, Reuters reported. The Indian Medical Association said private hospitals in the western city of Surat may soon shut down if they don’t receive supplies of oxygen. Delhi is in lockdown, as is the hard-hit western state of Maharashtra and the southern state of Karnataka, Reuters noted. Heart-wrenching images of bodies piled into makeshift crematoriums have spread around the world.

Experts blame relaxed health measures, low vaccination rates, and the spread of more transmissible coronavirus variants for the explosive surge.

Outpouring of aid

With the tragedy ongoing, countries around the world rushed to aid India. Officials in Delhi received a shipment from Britain, including 100 ventilators and 95 oxygen concentrators, Reuters’ partner ANI reported Tuesday. France is sending oxygen generators able to provide 250 patients with a year’s worth of the gas, Reuters added.

Singapore sent oxygen containers to India on Saturday while Germany was airlifting 23 mobile oxygen generation plants to the country, The Washington Post reported Sunday. India worked with private companies to bring over 80 metric tons of liquid oxygen from Saudi Arabia, the Post noted. Russia has also offered help, and Pakistan is ready to provide ventilators, digital X-ray machines, personal protective equipment, and other supplies, according to a tweet Saturday from Pakistan’s foreign minister. Even China, which has been in a year-long military dispute with India at the Himalayan border, said it was working on sending medical supplies, Reuters added.

The US is also among those eager to help the distressed country. In addition to the delayed vaccine doses, senior Biden administration officials said in a background call with reporters Monday that the country is working on offering oxygen generation systems, ventilators, therapeutics, personal protective equipment, and tests.

The Centers for Disease Control and Prevention and the United States Agency for International Development are sending “strike teams” of public health experts to help with laboratory services, surveillance, epidemiology, bioinformatics for variant sequencing and transmission modeling, vaccine rollout, and risk communication.

Lastly, though the US can’t yet send already-made doses of AstraZeneca’s vaccine to India, administration officials have diverted US orders of supplies for making AstraZeneca’s vaccine directly to India.





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