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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.

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.
Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

Things are not looking good for Emergent BioSolutions, the contract manufacturer that ruined 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine and millions more doses of AstraZeneca’s COVID-19 vaccine at its production facility in Baltimore.

The Food and Drug Administration on Wednesday released a searing inspection report of the facility, finding a slew of significant violations and failings.

Meanwhile, federal lawmakers have opened a multi-pronged investigation into whether Emergent used ties to the Trump administration to get billions of dollars in federal contracts despite a history of failing to complete contracts, inadequately training staff, persistent quality-control issues, and an “unjustified” 800% price increase for an anthrax vaccine.

In a letter sent to Emergent’s top executives Tuesday, Rep. Carolyn Maloney, chairwoman of the House Committee on Oversight and Reform, and Rep. James Clyburn, chairman of the Select Subcommittee on the Coronavirus Crisis, laid out the investigation, writing:

Emergent received $628 million in June 2020 to establish the primary US facility for manufacturing vaccines developed by Johnson & Johnson and AstraZeneca. Dr. Robert Kadlec, who served as Assistant Secretary for Preparedness and Response under President Trump and previously worked as a consultant for Emergent, appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfill the contract.

800% drain

But the investigation stretches back much farther than the start of the pandemic—through years of questionable federal contracts.

In 1998, Emergent (then called BioPort) bought the license to an anthrax vaccine. The vaccine, BioThrax, was approved by the FDA in 1970 but remains the only FDA-approved vaccine for anthrax. As such, Emergent is the sole supplier of anthrax vaccine for the federal government’s Strategic National Stockpile (SNS). When Emergent bought the vaccine in 1998, a dose went for about $3.35. By 2010, the price was up to $28 a dose. Now, the price is over $30, and average wholesale prices are even higher, reaching $90 per dose, the lawmakers note.

“Emergent has raised the government purchasing price of the anthrax vaccine by 800% since acquiring the drug in 1998,” the lawmakers write in their letter. “As a result, through most of the last decade, nearly half of the SNS’s budget has been spent purchasing Emergent’s anthrax vaccine. These spiraling costs contributed to shortages of critical supplies, including ventilators, reusable respirator masks, and other personal protective equipment, which severely impacted the government’s ability to respond to the coronavirus crisis.”

This drain on the SNS budget was particularly apparent during the pandemic—which Robert Kadlec, the former Emergent consultant, himself acknowledged.

Kadlec was nominated in 2017 by President Trump to lead the Office of the Assistant Secretary for Preparedness and Response (ASPR). Following his confirmation, Emergent received millions of dollars in federal contracts from ASPR, including contracts for the SNS that were awarded without competitive bidding, the lawmakers note in their letter.

In 2020—just before the pandemic hit the US—Kadlec’s office awarded Emergent around $3 billion in long-term contracts for anthrax and other bioterrorism threats. According to the lawmakers, Kadlec later suggested this was a bad move, saying: “If I could spend less on anthrax replenishment, I could buy more N95s. I could buy more ventilators. I could buy more of other things that quite frankly I didn’t have the money to buy.”

Failures and an inspection

Aside from the skyrocketing prices, the lawmakers suggest Emergent didn’t even deserve the contracts in the first place. In 2012, the Department of Health and Human Services awarded Emergent a $163 million contract to renovate its (currently troubled) Baltimore manufacturing plant. The idea was for the plant to become a manufacturing hub for rapidly producing vaccine in the event of an infectious disease outbreak or bioterror attack. Part of the contract stipulated that Emergent would be required to do a test run, producing 50 million doses of a pandemic influenza vaccine in the span of four months, and obtain manufacturing approval from the FDA by June 2020.

Emergent failed to meet those requirements.

Reading the FDA’s inspection report of Emergent’s Baltimore facility, it’s clear why. During the nine-day inspection, which ended April 20, FDA inspectors logged a long list of problems at the facility.

First on the list is that Emergent failed to thoroughly investigate how the millions of Johnson & Johnson and AstraZeneca doses became contaminated. The agency concluded that, without a thorough review of what happened, it’s possible that other finished batches of vaccine may also be ruined. “There is no assurance that other batches have not been subject to cross contamination,” the inspectors wrote.

The FDA inspectors went on to note unsanitary conditions, paint peeling off of the walls and floors, residue on equipment, improperly trained staff, and numerous opportunities for vaccine products to be contaminated.

The potential for cross contamination—spread of viral ingredients back and forth between Johnson & Johnson’s vaccine and AstraZeneca’s vaccine—appeared rampant at the facility. Inspectors witnessed Emergent employees dragging unsealed, non-decontaminated bags of medical waste across different manufacturing areas. In some cases, employees tossed bags of medical waste, unsealed, into a service elevator. Emergent did not have proper written procedures for how to decontaminate waste, the inspection report notes. Security footage also caught employees moving from different areas of the facility without following proper procedures for donning and removing protective gowns.

At the request of the FDA, vaccine production at the Baltimore facility has been halted since April 16.

In a statement Wednesday, Emergent said that the FDA’s findings “provide direction on the necessary steps to improve operations.” The company went on:

The FDA’s feedback will help us continue to improve and strengthen the supply chain for Johnson & Johnson’s COVID-19 vaccine. While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.

A large streetside sign for a Johnson and Johnson vaccine.
Enlarge / General exterior view of the head office of Janssen pharmaceutical company on April 15, 2021 in Leiden, Netherlands.

About 88 percent of Americans support the pause of Johnson & Johnson’s COVID-19 vaccine, and the pause did not increase vaccine hesitancy, according to fresh data from the Axios-Ipsos Coronavirus poll.

The finding is likely to hearten public health experts, who have faced criticism and concern that the pause could erode confidence in vaccine safety and fortify already high-levels of vaccine hesitancy in the country.

The Centers for Disease Control and Prevention, along with the Food and Drug Administration, recommended a pause in the use of the Johnson & Johnson vaccine on April 13 after linking the one-dose vaccine to six cases of a rare blood-clotting condition, one of which was fatal. The six cases occurred among more than 6.8 million people given the vaccine, suggesting that if the blood clots are, in fact, a side effect of the vaccine, they are an extremely rare side effect.

Many experts defended the pause by arguing that the hiatus and full evaluation of the potential serious side effect—even if it’s only a one-in-a-million occurrence—prove that stringent safety monitoring and precautions are in place. Americans largely appear to agree.

In the latest poll, the market research firm Ipsos first asked if people had heard of the pause. An impressive 91 percent of respondents said they had. Of those who said they were aware of the pause, 88 percent responded “Yes” to the question: “Do you believe the FDA and CDC are being responsible by recommending a pause on the distribution of the Johnson & Johnson vaccine?”

The poll was conducted between April 16 and 19 by Ipsos, which drew on a nationally representative probability sample of 1,033 general population adults, ages 18 or older. For questions posed to all 1,033 people, the margin of sampling error is ±3.3 percentage points at the 95 percent confidence level.

Impotent pause

The poll also suggested that the Johnson & Johnson pause has not increased or decreased vaccine hesitancy.

As in every other previous poll going back to last August, Ipsos pollsters asked everyone: “How likely, if at all, are you to get the first-generation COVID-19 vaccine, as soon as it’s available?” A total of 70 percent said they were likely to get a vaccine or had already gotten a vaccine, while a total of 30 percent said they were “not very likely” or “not at all likely” to get a vaccine.

The total of 70 percent in the “likely/already had” category is basically unchanged from recent polls. In the poll conducted between April 2 and 5, a total of 71 percent of respondents fell into that category, while the total was 69 percent during the poll conducted between March 19 and 22. The same lack of change was seen in the “not likely” category, which also wobbled between an insignificantly different 29 percent and 30 percent in the two previous polls.

Moreover, the numbers are significantly better than the peak of vaccine resistance seen in a late September poll. That’s when only 37 percent said they were likely to get vaccinated and 63 percent said they were not likely to get vaccinated.

Cliff Young, president of Ipsos US Public Affairs, told Axios that “People are unfazed” by the Johnson & Johnson vaccine pause. “The way forward is about the vaccine, so if there’s any stumble, people are going to pay attention to it—but it hasn’t had an impact thus far” on people’s willingness to get the vaccine.

“Not sustainable”

The same results were found in a focus group of vaccine-hesitant Trump voters, according to a report by The Washington Post. Frank Luntz, a longtime GOP communications expert, held the focus group over Zoom on Sunday, involving 17 conservative participants. Throughout the pandemic, Republicans and conservatives have been among the most consistent groups to tell pollsters that they are unwilling or hesitant to get a COVID-19 vaccine. In a recent Kaiser Family Foundation poll, a total of 35 percent of Republicans surveyed said they would definitely not get vaccinate or only get vaccinated if vaccination was required.

The Johnson & Johnson vaccine pause is not changing their thinking one way or the other, according to the focus group. The group largely shrugged off the pause and questioned why the CDC and FDA halted use for a potential side effect that is so rare, the Post reported. “A lot of people might want to take the Johnson & Johnson vaccine versus the others, because it’s one shot versus two,” said a focus-group participant identified as Cathy from Pennsylvania. An epidemiologist who helped convene the focus group further noted to the Post that “we didn’t see folks really concerned with the pause in the J&J vaccine.”

Instead, focus group members were more concerned about recent reports that Pfizer CEO Albert Bourla suggested people may need to get a COVID-19 booster shot within a year. “I feel like this is not going to end,” said a focus-group participant identified as Erzen from New York. “I mean, we’re just going to be shot up and shot up and shot up. We can’t live like this. This is not sustainable.”

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's Covid-19 vaccine, in Baltimore, Maryland, on April 9, 2021.
Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s Covid-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

The US Food and Drug Administration last week asked Emergent BioSolutions to stop making Johnson & Johnson’s COVID-19 vaccine at its troubled facility in Baltimore, according to a regulatory filing Emergent released Monday.

The FDA had begun an inspection of the contract manufacturer’s facility on April 12 but requested on April 16 that production be halted “pending completion of the inspection and remediation of any resulting findings,” the filing reads. Any vaccine materials already made at the plant will be held in quarantine.

The production halt follows news last month that a mishap at the plant led to the ruin of 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine. The ruined doses had reportedly been contaminated with ingredients from AstraZeneca’s COVID-19 vaccine, which was also being manufactured at the plant at the time.

The accident was a major stumbling block for Johnson & Johnson’s vaccine production—but not a consumer safety issue. All of the doses of Johnson & Johnson’s vaccine that has been used in the US so far have been produced in the Netherlands. The Emergent facility in Baltimore had not yet been authorized by the FDA for vaccine production when the doses were ruined, and none of the spoiled doses completed the production process.

Early this month, the Biden administration put Johnson & Johnson in charge of the facility and ordered AstraZeneca’s vaccine production out to prevent further cross-contamination problems. At the time, the company said that, despite the setback, it still expected to meet its commitment to deliver nearly 100 million doses of its vaccine to the US government by the end of May. But the current production pause again raises questions of whether the company will still be able to meet that goal.

“At this time, it is premature to speculate on any potential impact this could have on the timing of our vaccine deliveries” the company told Reuters.

In a statement to Politico, Emergent said:

While we await the FDA’s full feedback, we are working with J&J and the FDA on strengthening the supply chain for this vitally important vaccine… We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes.

Pause beyond pause

For now, Biden officials say they have enough vaccine supply from Moderna and Pfizer-BioNTech to continue the current pace of vaccinations, which has exceeded 3 million doses a day recently.

Regardless of the production pause, use of Johnson & Johnson’s vaccine was already on pause as federal health experts and advisors review data linking the vaccine to an extremely rare but dangerous blood-clotting condition.

Last week, the FDA and the Centers for Disease Control and Prevention said that, out of more than 6.8 million vaccine doses administered, they had identified six cases of the unusual condition, which leads to dangerous life-threatening blood clots in combination with low levels of platelets. One person died of the condition, and another was said to be in critical condition.

A vaccine advisory committee for the CDC, called ACIP, held an emergency meeting last week but punted on making any recommendations for use of Johnson & Johnson’s vaccine going forward. Instead, the committee scheduled another public meeting for this Friday, April 23 from 11 am to 5 pm EDT where it will review further data and analyses.

In a White House press briefing Monday, CDC director Rochelle Walensky said that the agency had received additional reports of blood-clotting cases possibly linked to the vaccine.

There have been “a handful of cases, not an overwhelming number of cases,” Walensky said in the briefing. “We are working through and adjudicating them and verifying whether they do in fact reflect a true case.” The CDC and the FDA will then present their findings to ACIP on Friday, she said.

Image of a woman receiving a vaccine.
Enlarge / A nurse practitioner named Heidi Johnson administers a vaccine from Johnson & Johnson.

On Tuesday morning, the US Centers for Disease Control and Food and Drug Administration issued a release acknowledging an extremely rare clotting disorder was associated with the use of the Johnson & Johnson COVID vaccine. The problem is actually less than a one-in-a-million issue; in data from the US, where 6.8 million doses of this vaccine have been used, there have only been six instances of the clotting problem detected.

Because the clots call for an unusual treatment, however, the organizations are calling for a pause in administering the shot. This will provide them with time to ensure the medical community is aware of the appropriate treatment.

This is not the first vaccine to create extremely rare clotting issues. They’ve also been seen following use of the AstraZeneca vaccine. The problem appears to be caused by the harmless virus (an Adenovirus) that carries a single gene from SARS-CoV-2 in order to elicit an immune response.

Apparently, in very rare cases, the Adenovirus triggers an immune response to factors found on the surface of platelets, which are an essential part of the clotting process. This activates platelets, causing clots, and at the same time reduces the total platelet count.

These seemingly contradictory changes make treating it through the normal approach to excessive clotting dangerous. Typically, the appearance of clots would call for using a treatment that would reduce the probability of clots forming. But, due to the low platelet counts in these individuals, those treatments can make it much less likely that clots form when they’re needed.

It’s this difference between apparent patient needs and appropriate treatment that has caused the CDC and FDA to call for a pause in the use of the J&J vaccine.

CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

The CDC and FDA highlight severe headache, abdominal pain, leg pain, or shortness of breath as potential symptoms of the clotting problem.

So far, all six cases have occurred among women below the age of 50 and appeared between one and two weeks after vaccination. Because of the rarity of the clotting disorder compared to the very large risks posed by COVID-19, most countries that initially suspended the use of the AstraZeneca vaccine re-started it with added precautions. Germany, for example, is using it for patients over 60, since they are at lower risk of clots and much higher risk of severe COVID-19.

It’s likely that the US will also resume use of the J&J vaccine, which still has an excellent overall safety profile, typically has lower side effects than two-dose vaccines, and is extremely effective.

Unfortunately, the US also has a large population of people who are hesitant about receiving any vaccines. Given their persistent worries, these events will likely feed into their paranoia. And their apparent resistance to facts will make it much harder for them to evaluate the risk calculation of an extremely rare side effect in a vaccine against a virus that’s frequently deadly.