The USA can do better to protect emerging global health threats for hundreds of millions of Americans and for billions of people around the world.

The Joe Biden-Kamala Harris administration and its allies in Congress have already posted an impressive track record of early efforts to revive and champion U.S. leadership in global health. The American Rescue Plan, proposed by President Biden in January and passed in March, includes significant emergency funding to support the international COVID-19 response through initiatives like the Global Fund to Fight AIDS, Tuberculosis and Malaria; a multilateral vaccine development partnership; the President’s Emergency Plan for AIDS Relief; and global health programs at the US Agency for International Development (USAID). 

America’s shift to tackle COVID-19 beyond our borders cannot happen fast enough. 

Every day, this depressingly unyielding pandemic serves up reminders of not only the power of biomedical research and development (R&D) to deliver amazing innovations—several vaccines developed and deployed in just over a year—but also of the shocking disparities in gaining access to them. Low- and middle-income countries, despite being home to 85% of the global adult population, account for only 49% of COVID-19 vaccine doses administered worldwide.

With awareness of the importance of global health R&D at an all-time high—and global health champions now aligning to pull levers of power at both ends of Pennsylvania Avenue—policymakers have an opportunity to provide investments and reforms that can help us emerge from the pandemic primed to conquer a number of stubborn global health foes. Seizing this moment will involve building on the successes of the last year and learning from the failures.

As Congress and the administration get to work on the FY2022 federal budget, here are six things they can do to provide much better protection from enduring and emerging global health threats for hundreds of millions of Americans and for billions of people around the world.

US Aid need to increase its funding for Research and Development.

1. Double Funding for Global Health Programs at USAID. From these increases, USAID should set minimum funding targets for the agency’s R&D work, establish a new chief science and product development officer position and create a $200 million USAID Grand Challenge for health security. USAID is the only U.S. agency with a mandate to focus on global health and development. Yet despite its track record of delivering high-impact health innovations, funding for global health R&D has waned in recent years and the agency’s unique capabilities have been underutilized and underfunded as part of the US government’s COVID-19 response. The American Rescue Plan includes funding that recognises USAID’s importance in combating COVID-19 and advancing global health. We need to build on this progress.

2. Increase Support for the Centre for Disease Control and Prevention – especially for its Centre for Global Health, the National Centre for Emerging and Zoonotic Infectious Diseases, and the Division of Tuberculosis Elimination and its Tuberculosis Trial Consortium. These programs have been operating on tight and relatively stagnant budgets even before COVID-19 diverted critical resources and expertise.

3. Provide Targeted Funding for Product Development and Translational Research Lacking Commercial Interest.

There is also a need for steady funding increases at the Fogarty International Center and sustained growth for the National Institute of Allergy and Infectious Diseases and the Office of AIDS Research. The National Institutes of Health’s high-profile work in confronting COVID-19 has highlighted the importance of past investments. But the pandemic also drained dollars and diverted talent from non-COVID priorities.

4. Establish a Permanent Funding Line at the Biomedical Advanced Research and Development Authority (BARDA) of at least $300 million annually to support work on emerging infectious diseases—a category of which COVID-19 is a high-profile, but not singular, example. Despite its proven value in dealing with a range of threats, BARDA has been overly reliant on “one-off” emergency supplemental appropriations for threats like Ebola and Zika, leading to dangerous gaps in its portfolio when limited funding runs dry. BARDA should also expand its research on antimicrobial resistance (AMR) to include drug-resistant tuberculosis (TB), which is a major health security threat to the United States. 

5. Protect Department of Defence Programs Focused on Malaria and Other Parasitic Diseases, TB and AMR. There have been internal proposals to potentially eliminate DoD’s malaria research programs, which would scuttle decades of progress achieved via research at the Walter Reed Army Institute of Research and the Naval Medical Research Center—despite malaria remaining a leading threat to U.S. troops deployed abroad. DoD’s efforts to develop new treatments for drug-resistant pathogens, which include dangerous strains of TB, are also essential to achieving global health security.

6. Increasing Support for Key Multilateral Initiatives, like the Coalition for Epidemic Preparedness Innovations (CEPI). Formalizing U.S. support for CEPI and committing at least $200 million annually would provide a much-needed boost to an initiative dedicated to developing vaccines against epidemic threats and making them globally accessible—but first, the U.S. should provide CEPI with $300 million of the global health funding just passed in the American Rescue Plan to boost its work on COVID-19. Also, Congress can support efforts at the Food and Drug Administration to provide technical support to under-resourced regulatory authorities around the world, which could accelerate access to a range of biomedical advances.

Together, these six recommendations can form the core of a broader effort to supercharge America’s global health R&D capabilities. Whether the motivation is to protect Americans from threats that have no respect for geography, to advance health equity around the world, or somewhere in between, the United States must take decisive action to resume its leadership in global health R&D.

Jamie Bay Nishi

Jamie Bay Nishi is director of the Global Health Technologies Coalition (GHTC), a coalition of more than 30 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics and other tools that bring healthy lives within reach for all people. For more information, read GHTC’s agency-by-agency blueprint for supercharging global health R&D: Meeting the moment, fueling the future: Policy recommendations for a new era of US leadership in global health R&D

 

Image Credits: Global Health Technologies Coalition.

Transparency in medicine pricing is a key theme of the Fair Pricing Forum that started this week.

The World Health Organization (WHO) and the World Trade Organization (WTO) both are hosting key global meetings aimed at improving global access to COVID-19 vaccines and fair medicine prices this week behind closed doors.

The WHO Fair Pricing Forum started on Tuesday and its stated aim is to activate “additional support for countries to achieve more affordable and fairer access to pharmaceutical products during the COVID-19 pandemic and beyond”.

Meanwhile, on Wednesday, the WTO Director General, Ngozi Okonjo-Iweala, will host a meeting on “COVID-19 and Vaccine Equity: What can the WTO Contribute”.

The Fair Pricing Forum (FPF), supported by the Ministry of Health of Argentina and running virtually until 22 April, is likely to focus on transparency of medicine prices and production as well “upstream innovation” aimed at widening the manufacturers’ pool. 

This is according to Suerie Moon, co-director of the Global Health Center of the Graduate Institute of Geneva and a member of the FPF expert advisory group, who describes the forum as an “important space for governments to connect and co-operate”.

Transparency and the Innovation System

“There’s a lot of focus on transparency in the agenda. COVID-19 raised public awareness of the problem of confidentiality. But there is a lot governments can do on transparency that they haven’t yet done – there also needs to be a strengthening of backbones,” she said. 

Moon added that linking high prices to the underlying innovation system “has never been so front and centre of discussion as it is now”.

“There is an entire strand of the conference on innovation, looking at how governments can change innovation incentives, how they can rewrite the rules that structure innovation and pricing of medicines,” said Moon, of the meeting, which paradoxically is taking place away from the media and public eye..

She added that while the discussion in the WTO’s TRIPS Council over the IP waiver is split along predictable North-South lines, more informal alliances are easier to build at the Forum where there are “challenges common to countries in the North and South and shared concerns vis-à-vis the medicine pricing practices of the pharmaceutical industry”.

Health Policy Watch has seen two discussion papers to be discussed at the Forum, which look at how medicines pricing could be made more “sensitive to health systems’ ability to pay”, and “incentives for pharmaceutical innovation to achieve fair pricing” respectively. These were developed by two technical working groups formed at the last FPF meeting in South Africa in 2019.

Global Framework to Address Pricing

The first paper suggests a global framework to tackle the “unaffordability of medicines and vaccines”. It also flags that the lack of transparency relating to prices and contracts undermines good governance ‘especially when the public expects full accountability for public spending’. 

It highlights the success of cross-border collaborative initiatives in ensuring more affordable medicines, including global initiatives such as Stop TB Partnership’s Global Drug Facility; the Medicines Patent Pool; Gavi, the Vaccine Alliance; and the WHO co-sponsored COVAX global vaccine facility; as well as regional efforts including the Pan American Health Orgqanization’s “Revolving Fund for Vaccine Procurement” and the Beneluxa initiative of smaller European countries, including Belgium, the Netherlands, Luxembourg, Austria and Ireland, to coordinate policies on pharma purchases and pricing.

The second paper argues that ‘“pharmaceutical innovation is a hybrid public and private effort”, with the public sector paying for about 30% of the upfront total investment in pharmaceutical R&D and the private sector paying for about 60% of upfront investment in the later, relatively lower-risk stages, with the remaining 10% coming from sources such donors.

It also flagged the need for “frameworks for global governance”, noting that “the bilateral agreements for COVID-19 vaccines are a sober reminder that public sector stewardship at the national level sometimes may serve narrower national interests at the risk of disregarding larger issues of global health equity”. 

WTO Invites Wide Range of Pharmaceutical Companies 

WTO Director-General Ngozi Okonjo-Iweala

Meanwhile, the WTO’s Wednesday meeting includes various trade ministers, including those from the European Union and the United States, as well as India and South Africa, which are co-sponsors of the WTO proposal to waive intellectual property rights on COVID-19 health products for the duration of the pandemic.

A wide range of pharmaceutical companies are also invited, including representatives from Pfizer, Moderna and Astra Zeneca, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA); the Developing Countries Vaccine Manufacturers Network,  the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Japan Pharmaceutical Manufacturers Association (JPMA).

Speaking at meetings in the US last week, Okonjo-Iweala said that equitable worldwide access to COVID-19 vaccines “is necessary for economic growth and trade to bounce back from the pandemic and that a reinvigorated multilateral trading system would strengthen both the health response and the economic recovery”.

The first session of the  WTO meeting focuses on challenges to “equitable vaccine distribution”, including a focus on export restrictions and trade barriers.

Thomas Cueni, IFPMA Director General, confirmed to Health Policy Watch that his association and a number of its member company experts “have accepted the Director General’s invitation to speak at the WTO event”.

‘“We believe this is an important opportunity to contribute to the DG’s expressed desire to find pragmatic outcomes to increase vaccine production.  We hope to be able to share our experience of the complexities in researching, developing, registering, manufacturing and distributing COVID-19 vaccines,” said Cueni

However, over 240 civil society organisations wrote an open letter to Okonjo-Iweala on Tuesday expressing concern “over the emphasis on industry-controlled bilateral agreements as the primary approach to addressing global production constraints and supply shortages”.

Referring to her “Third Way” approach, which they described as “appealing to pharmaceutical corporations to take voluntary actions”, the organizations said this had “proven to be insufficient in this pandemic”.  

Instead, they proposed that WTO member states approve the initiative to remove “barriers towards the development, production and approval of vaccines, therapeutics and other medical technologies necessary for the prevention, containment and treatment of the COVID-19 pandemic” by supporting the temporary waiver on intellectual property rules.

 

 

Image Credits: WHO, ©WTO/Bryan Lehmann.

Pangolin, Manis javanica – a mammal that can harbor coronavirus infections; huting for its meat and scales have made it one of the world’s most endangered species.

In an unusually bold step for the cautious global health agency, the World Health Organization has called upon countries to suspend the sale of captured live wild mammals in food markets as an emergency measure.

The appeal follows on the publication of a report by a WHO-convened international team examining the origins of the SARS-CoV2 virus – which found that one of the most likely routes by which the virus may have first infected people was via wild food markets. Such markets are a well entrenched tradition in parts of Southeast Asia and China, including cities such as Wuhan, where the first novel coronavirus case clusters visibly appeared in December 2019.

In the closed and contained surroundings of such markets, scientists have long maintained that it’s highly possible a wild mammal such as a pangolin, itself an endangered species, could have conveyed the SARS-CoV2 virus to humans – either directly or indirectly from another infected animal source such as horseshoe bats. Horsehoe bats, which are indigenous to southwestern China’s Yunnan Province, have been found to harbor coronaviruses that are among those most genetically similar to the SARS-CoV2.

The call by WHO is only for an “emergency” suspension of wild animal trade and slaughter at food markets – and it is limited to mammals – rarther than including reptiles and other species that can also harbor and carry dangerous viruses. But it is still unprecedented.

Live animal markets in China have been the source of previous coronavirus outbreaks, including the 2003 SARS,  In that case, Asian Palm Civets, infected by horseshoe bats, reportedly carried the virus to humans working or shopping in the markets.
WHO Traditionally Avoided Strong Policy Advice on Upstream Causes of Foodborne Diseases

WHO has traditionally steered clear of definitivie policy advice to ban or curb activities related to the upstream causes of foodborne disease – and which touch heavily on local economies, food sources, cultural sensitivities and traditions.

For instance, it has taken years for the agency to gingerly take up even a few cautious statements that support less meat consumption in diets overall – despite the overwhelming evidence that diets heavy in red meat, in particular, are bad for both health, and climate/environment.

And in the case of the much more widely discussed issue of air pollution, which still killed more people annually than COVID-19, WHO has avoided direct calls for similar restrictions or bans on the production or sale of pollution sources, such as highly polluting second hand vehicles – which are among the leading sources of air pollution in fast-growing low- and middle-income cities today.

Equally noteworthy is the fact that the WHO statement on the wild mammal trade and slaughter was issued jointly with the World Organization for Animal Health (OIE) and the United Nations Environment Programme.  It is one of the more immediate signs that the agencies are indeed taking up a “One Health” approach to the pandemic that they have talked about so much – and thereby also tackling other upstream causes of foodborne diseases in the food production and supply chain.

While the WHO appeal, and the companion guidance it has issued on reducing public health risks from live animal markets, is hardly likely to make an immediate dent in the very widespread practice in Asia and Africa of wild mammal capture and sales – it is still a modest starting point.

It signals  the growing recognition of zoonoses from wildlife as a key cause of new and emerging pathogens – which have bequeathed the world HIV/AIDS, Ebola, SARS and now COVID19 in recent decades, to name only a few diseases.  And while many wild animals can harbor dangerous diseases, it is mammals, the closest relatives to homo sapiens, that generally harbor the viruses of greatest danger to people, the guidance notes.

“To reduce the public health risks associated with the sale of live wild animals for food in traditional food markets, WHO, OIE and UNEP have issued guidance on actions that national governments should consider adopting urgently with the aim of making traditional markets safer and recognizing their central role in providing food and livelihoods for large populations,” the guidance states.

“In particular, WHO, OIE and UNEP call on national competent authorities to suspend the trade in live caught wild animals of mammalian species for food or breeding purposes and close sections of food markets selling live caught wild animals of mammalian species as an emergency measure,” the guidance further adds.

“Although this document focuses on the risk of disease emergence in traditional food markets where live animals are sold for food, it is also relevant for other utilizations of wild animals. All these uses of wild animals require an approach that is characterized by conservation of biodiversity, animal welfare and national and international regulations regarding threatened and endangered species.”

Nod to Traditional Cultures – Stops Short of Calling For Permanent Bans on Trade and Market Slaughter of Wild Mammals
Seafood and fresh food market in Wuhan, Hubei, China. Most confirmed cases of 2019-nCoV were traced back to Huanan Wholesale Seafood Market, although at some of the early cases never visited the market.

The guidance notes that traditional food markets are an important part of “the social fabric of communities and are a main source of affordable fresh foods for many low-income groups,” as well as being an important source of livelihoods for millions of people.

“Significant problems can arise when these markets allow the sale and slaughter of live animals, especially wild animals, which cannot be properly assessed for potential risks – in areas open to the public. When wild animalsii are kept in cages or pens, slaughtered and dressed in open market areas, these areas become contaminated with body fluids, faeces and other waste, increasing the risk of transmission of pathogens to workers and customers and potentially resultingin spill over of pathogens to other animals in the market.”

While the exact pathway by which the SARS-CoV2 infection entered the human population has not yet been identified – and some scientists believe that the virus may have even escapted from a laboratory research facility where coronaviruses were being studied – rather than first being spread through the food chain, the legacy of foodborne transmission of other coronaviruses in Asia’s traditional food markets is an established fact that WHO highlights.

“Such environments provide the opportunity for animal viruses, including coronaviruses, to amplify themselves and transmit to new hosts, including humans. Most emerging infectious diseases – such as Lassa fever, Marburg haemorrhagic fever, Nipah viral infections and other viral diseases – have wildlife origins. Within the coronavirus family, zoonotic viruses were linked to the severe acute respiratory syndrome (SARS) epidemic in 2003 and the Middle East respiratory syndrome (MERS), which was first detected in 2012,” the guidance further notes.

Freshly slaughtered animals in a market in Wuhan, Hubei, China,hanging above conventional produce

Not only that, but “animals, particularly wild animals, are reported to be the source of more than 70% of all emerging infectious diseases in humans, many of which are caused by novel viruses. Traditional markets, where live animals are held, slaughtered and dressed, pose a particular risk for pathogen transmission to workers and customers alike.

“To mitigate this risk, an immediate emergency measure for regulatory authorities would be to introduce regulations to close these markets or those parts of the markets where live caught wild animals of mammalian species are kept or sold to reduce the potential for transmission of zoonotic pathogens,” the guidance states.

However, the guidance stops far short of calling for a permanent ban on the sales of wild mammals in traditional markets.

Rather it states that the “emergency measures should be of a temporary nature while responsible competent authorities conduct a risk assessment of each market, to identify critical areas and practices that contribute to the transmission of zoonotic pathogens.

“Competent authorities should work with market managers to introduce measures to mitigate identified risks. Markets or section of markets should be allowed to reopen only on condition that they meet rquired food safety, hygiene and environmental standards.”

The guidance also stops far short of suggesting that wlidlife farms, which may have been an upstream source of the first SARS-CoV2 infections, be closed, stating only that authorities need to ensure that live, caught wild animals “are not illegally introduced to wildlife farms, thus increasing the risk of transmission of zoonotic pathogens circulating in wild populations.”

Live chickens await slaughter at a traditional market in Xining, Lanzhou, China. Along with mammals, live poultry also harbor pathogens that have lept to humans, in episodes such as the H5N1 outbreak of avian influenza of the late 1990s.

Rather it sugggests that “farms that produce wild animals need to be registered, approved and inspected for animal health and welfare standards by relevant competent authorities.”

However the guidance does suggest that there should be a phasing out of the slaughter of live wild animals in market areas that are frequented by shoppers and members of the public.

“Such strategies envisage phasing out live animal marketing and slaughter in proximity to the public or physically separating such activities to reduce the risks of transmission of zoonotic diseases. Slaughter and dressing should be carried out in suitable facilities under control of the official veterinary service for ante- and post-mortem inspections,” the guidance states. “Key areas needed for inclusion in plans to upgrade hygiene and sanitation standards are sanitary facilities (toilets, hand washing), pest control, waste management and disposal (solid and liquid wastes), drains and sewage disposal. Food handling and marketing activities should be moved to wellmaintained stalls where surfaces can be easily washed and disinfected.”

Link here for the complete guidance document. 

 

Image Credits: Piekfrosch/wikipedia, lihkg.com, Arend Kuester/Flickr, Arend Kuester/Flickr, Flickr/M M.

united states
Vials of Johnson & Johnson’s vaccine.

The United States’ Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have recommended a “pause” in administration of Johnson & Johnson’s (J&J) single-dose COVID-19 vaccine out of an “abundance of caution” following six cases of a rare type of blood clotting among the 6.8 million US recipients of the vaccine. 

The six reported cases had a rare and severe type of blood clot, called cerebral venous sinus thrombosis (CVST), in addition to low levels of blood platelets (thrombocytopenia). 

The same kind of adverse effect has been noted in Europe among recipients of the AstraZeneca vaccine in Europe – where some 62 cases of the rare disorder have been seen among the 34 million people vaccinated as of 4 April. So far, however, the AstraZeneca vaccine has not been approved in the United States – while the J&J vaccine is only just starting to be rolled out in Europe, following regulatory authorization there in mid-March.   

While an anticoagulant drug called heparin is typically used to treat blood clots, alternative treatments are needed for CVST – which combines clotting with low platelet levels. 

In the case of the J&J jabs, all six cases occurred in women between the ages of 18 and 48, with symptoms occurring 6 – 13 days following vaccination.  That, too, follows a pattern similar to that seen in the AstraZeneca vaccine – where most of the CVST cases were also seen in women under the age of 60 – prompting some countries, like Germany, to halt administration of the vaccine to younger people generally. 

“Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the CDC, said. 

The pause is important to ensure that the health provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment needed for CVST, the agencies’ statement said. 

The European Medicines Agency was the first to announce a review of cases linked to the J&J vaccine on 9 April following four reports of blood clots.  Following a similar review of the AstraZeneca vaccine, the EMA last week reaffirmed that the vaccine was safe for use by all groups – but said that a label should be affixed to the vaccine warning of the rare blood clot potential. 

The White House said in response that the FDA/CDC announcement will not have “significant impact” on US vaccination plans. 

“We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine,” said Jeff Zients, White House COVID-19 Response Coordinator on Johnson & Johnson’s vaccine. 

As of 12 April, more than 6.8 million doses of the Johnson and Johnson vaccine have been administered in the US, making up less than 5% of recorded doses in the country. The US currently has secured Pfizer and Moderna vaccines for 300 million Americans. 

The CDC will convene in a meeting on Wednesday to further review the cases. The FDA will then review the analysis while also investigating cases. 

In a company statement,  Johnson & Johnson said that it is  “aware“ of the adverse events that occur from administration of the vaccine, and is working with medical experts and health authorities in both Europe and the US through the investigation. 

“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” the company said in its statement.

Image Credits: Johnson & Johnson, NBC News.

 

WHO’s Ranieri Guerra (left) as cited by Rai Report in a WhatsApp Message: “I sent a profuse apology to the Minister. In the end I went to Tedros and had the document withdrawn.” On right, Silvio Brusaferro of the Italian Institute of Public Health.

Italian prosecutors in the city of Bergamo, the epicentre of the country’s first COVID wave, are reportedly investigating Ranieri Guerra, a senior World Health Organization advisor, for misleading testimony and his role in the suppression of a WHO report into Italy’s coronavirus response “An Unprecedented Challenge“- which contained critical material about the Italian government’s actions in the early days of the pandemic. 

A series of leaked Whatsapp exchanges between Guerra and Silvio Brusaferro, head of the Italian Institute of Public Health (Istituto Superiore di Sanità) published by the Italian investigative TV series Rai Report, suggest that Guerra pressured WHO to have the report retracted – not only to protect his own reputation as a former Italian Ministry of Health official in charge of prevention, but also to appease other powerful figures such as Brusaferro and the Minister of Health Roberto Speranza. 

“I was brutal with the fools in the Venice document,” Guerra reportedly told Brusaferro, president of the Public Health Institute, in reference to the report, authored in spring 2020 by a team in WHO’s Venice office, and withdrawn just hours after publication [ see previous Health Policy Watch Story]. “I sent a profuse apology to the Minister. In the end I went to Tedros and had the document withdrawn.” 

 

In another message, Guerra was quoted as telling Brusaferro that he was meeting with the Italian health minister’s cabinet chief about revising the report and that the minister’s office “said to see if we can make it fall into thin air. ”

Rai Report, in a Facebook post on its story, described the “dense plot of messages and meetings that emerges from WhatsApp chats contained in the rogatory that the prosecutor of Bergamo sent on 8 March to the World Health Organization. The rogatory, or request for legal assistance, was filed by Italy’s Ministry of Foreign Affairs, with WHO.

“The goal is to eliminate any trace of the critical report on Italy written by researchers in Venice. The deputy director of the World Health Organization Ranieri Guerra tells his moves to the president of the Istituto Superiore di Sanità, Silvio Brusaferro.

“Once the dossier was withdrawn, it had to be rewritten: it was the agreement between WHO, the Ministry of Health and the Istituto Superiore di Sanità to modify the text,” ” relates Rai Report, in the series of Facebook and Twitter posts, coinciding with its TV series. 

Bergamo Prosecutors Investigating Faulty Government Response To Pandemic 
Piazza di Spagna. Rome – Scenes from the suppressed WHO Report, An Unprecedented Challenge

While Guerra has not been charged with any crime, he is reportedly one of a number of people under investigation by Bergamo prosecutors for failing to disclose, or covering up, some of the events around Italy’s first COVID wave – and the related WHO report.  A document containing the Bergamo prosecutors’ concerns and allegations was sent to the Italian Foreign and Justice Ministries.  On 8 March, Italy’s Foreign Ministry sent a rogatory, or request for legal assistance, to WHO, citing the issues the prosecutors had raised. 

Prosecutors in Bergamo, the northern Italian town which became the epicenter for the initial outbreak of coronavirus that swept through the country in February and March of 2020, initially summoned Guerra, who also is a former official in the Italian Ministry of Health, to testify on the circumstances around the government’s initial response. Critics have described the response in Bergamo, in particular, as delayed and indecisive; authorities initially tried to maintain a business as usual approach in the city, even as the first clusters of COVD cases exploded in exponential terms.   

Guerra, who formerly headed the Ministry’s prevention activities, voluntarily agreed to be questioned by prosecutors  in November 2020. At the time of his testimony, Guerra, then WHO Assistant Director General for Strategic Initiatives, also was serving as WHO’s liaison with the Italian government to support its COVID-19 response. 

The report at the center of the controversy was pulled by the WHO from its website on 14 May 2020, just hours after its publication.  

Lead coordinator of the report, Francesco Zambon, later charged that the report had been withdrawn at the behest of Guerra to spare the Italian Ministry of Health embarrassment over its own state of preparedness – and particularly in order to avoid stains to Guerra’s own reputation as the MOH head of prevention between 2014 and 2017 – during a period when the Ministry had failed to update its 2006 pandemic preparedness plan. 

A series of email exchanges between Zambon and Guerra, previously published by Health Policy Watch, suggested that Guerra tried to get Zambon to alter key passages in the report, to suggest that the outdated pandemic plan from 2006 had indeed been “updated” under Guerra’s direction as the director general for prevention at the ministry – when it fact hadn’t been.

The WHO report is significant to the investigation of the enormous COVID-19 death toll seen in Bergamo, insofar as it contains details on the initial phase of response – and how an overall lack of national preparedness could have exacerbated the death toll.

Zambon – Slams “Conspiracy of Silence” Around WHO Report 
WHO’s Franceso Zambon has resigned after he spoke out against the Organization’s censorship of a report assessing Italy’s COVID-19 response.

Speaking to Health Policy Watch, Zambon said that the latest Rai Report, disclosures suggested that the decisions around the coverup of the Italian pandemic report extended much higher in the Italian government – and WHO circles – than he had previously imagined.  

“For me it’s quite disturbing in a way to see that the level of involvement and this kind of conspiracy of silence was such that I couldn’t have imagined,” Zambon said, referring to the report’s suppression. 

“Basically it emerges that there were personal interests of more than just one person [Guerra],” said Zambon. “Here, it seems that [WHO Director General] Tedros was involved, Kluge  (WHO Regional Director) is involved, Brusaferro, which is quite high in the Italian hierarchy, and also Minister of Health Speranza,” said Zambon.  “And this contradicts entirely the narrative that WHO has given so far. If you remember that at the WHO press conferences even Kluge said, absolutely no, this report was never withdrawn from political pressure, when according to this chat, that is exactly the opposite.” 

Zambon added that the issues raised by the suppression of the Italian report, An Unprecedented Challenge, also go to the heart of the controversy around the findings of a recent WHO-led investigation into the origins of the SARS-CoV2 virus – which critics have said is politically biased by China’s vested interests.

China has been keen to discredit some of the key hypotheses for how the virus may have emerged – and particularly the theory that the virus could have accidentally escaped from a Wuhan laboratory that was researching bat coronaviruses similar to SARS-CoV2. 

“The dynamics of power are the same: If WHO is not able to publish an independent report on a country like Italy, how can we think that WHO is able to publish an Independent report about a country like China,” Zambon asked, saying the issues raised by the pandemic report have re-emerged even more seriously in the current controversy around the SARS-CoV2 origins. 

Member States Need to Tackle Issue of WHO Independence

In light of both controversies, the independence of WHO needs to be addressed more frontally by WHO member states when the World Health Assembly meets this May, Zambon said:   

“This is now about how WHO functions. There is no independence in the way WHO works…I think that this should be discussed – the matter of WHO being able to carry out investigations –  which is not at the moment among the functions WHO can have, and this total lack of independence and transparency,” he said.  

“Member states need to tackle it [the issue],” he asserted further. “There might be political interests in not wanting to do that, but I think that maybe the civil society then should have a role.”  

Just last month, Zambon announced that he had resigned from WHO.  Speaking to Health Policy Watch on Monday, He said that he was effectively frozen out of his professional capacity, “mobbed” by colleagues, and thus “forced to resign” after publicly protesting the suppression of the report that had been produced by a team under his direction in WHO’s Venice Office for Investment for Health and Development. He said that he is now appealing his case through WHO’s internal justice procedure – after WHO refused to grant him whistleblower protections.    

WHO Denies Political Suppression – Claims Report Contained ‘Inaccuracies’  

WHO has repeatedly denied that the report, An Unprecedented Challenge, was suppressed for political reasons – or that Director General Tedros was personally involved.

WHO statements have insisted the decision to pull the report was taken by the WHO’s European Regional Office in Copenhagen – after certain factual inaccuracies were identified post-publication. 

In a statement to Health Policy Watch,  a WHO spokesperson repeated that stance again saying: “The director-general was not involved himself in the development, publishing or withdrawal of the report.”

The spokesperson added that the report, published by the WHO Regional Office for Europe, contained data and information that “had not been fact-checked and contained inaccuracies and inconsistencies. It should not have been published and it was withdrawn by EURO (under the authority of the Regional Director, EURO).”

In his former role as WHO Assistant Director General, and during the time the report was being developed, Guerra was assigned “on mission status” to support the Italian COVID-19 response, the first European country to face the full brunt of the pandemic in spring 2020,  the spokesperson also noted: “In this capacity he reported to both, the Director-General and the Regional Director , EURO, and he alerted both with regards to the need for checking of data and making appropriate corrections in the report.”

The spokesman added that Guerra was no longer a WHO Assistant Director General – but rather a “special adviser” to the Director General. 

According to other insiders, such positions, commonly awarded to senior staff who leave or retire from WHO, are typically held as consultancies, rather than full-time staff positions with the accompanying UN privileges and immunities from prosecution. 

In his response, Guerra, speaking through his lawyer, Roberto De Vita, warned Rai Report, that its reporting was “seriously damaging to the rights of Dr. R. Guerra, his personal and professional reputation and his role as a WHO official”.

Italy’s Agi news agency also quoted Guerra as saying he was shocked and “deeply embittered” that prosecutors had placed him under investigation, that he expected WHO to respond to them, and remained available for further clarification.

“I have been and am in absolute good faith and I am amazed that the prosecutors have a different impression,” Agi quoted him as saying. Guerra added that he told prosecutors everything he knew at the time but did not have access to all information.

– Updated on 13.04.2021

 

 

 

 

 

 

 

 

 

 

Image Credits: Rai report , WHO, An Unprecedented Challenge .

African vaccine producers supply just 1% of the continent’s needs at present – but the plan is to increase this to 60% by 2040, according to John Nkengasong, Director of the Africa Centers for Disease Control (CDC). 

“The vision is to ensure Africa has timely access to vaccines to protect public health security, by establishing a sustainable vaccine development and manufacturing ecosystem in Africa,” Nkengasong said at the opening of the two-day African Vaccine Manufacturing Virtual Conference on Monday.

There are currently 10 pharmaceutical manufacturing companies on the continent.

By deploying a coordinated regional strategy, Nkengasong said Africa can establish vaccine manufacturing hubs in each of the continent’s five regions — western, central, northern, eastern and southern.

If Africa is able to effectively leverage its capabilities, Nkengasong said the continent can vaccinate 60% of its people against COVID-19 by 2022. 

By 2040, he said Africa can be fully responsible for the manufacture of vaccines of three emerging diseases including Ebola,Lassa fever and Rift Valley disease; have capacity to manufacture vaccines for unknown global pandemic for up to 60% of its population, and should be able to meet 60% of its routine immunisation.

Dr Stavros Nicolaou, Aspen’s Senior Executive for Strategic Trade Development

In March 2021, South Africa’s largest pharmaceuticals maker, Aspen Pharmacare, announced it was involved in a technology transfer that will enable it to commence the supply of 200 million Johnson & Johnson COVID-19 vaccine doses before the end of June.

Dr Stavros Nicolaou, the company’s Senior Executive for Strategic Trade Development, told the conference that African governments need to ensure the availability of economies of scale, and to ensure the economies are sustainable.

“We cannot any longer sustain this continuous dependence on imports, particularly in the midst of a pandemic that we’re witnessing today, and for that matter any future pandemic,” Nicolaou  said. 

He said that the governments of Italy and France had approached Aspen for anesthetic and other supplies during the pandemic last year. 

He added that African governments and the continent’s major donor agencies have active roles to play in supporting local manufacturing through long-term contracts and guarantees of tax.

“Right now, with importing reigning supreme, there is no real support for localization and local efforts. It becomes very difficult to attract and retain investors. Without guarantees, we will not succeed,” he added.

To start with, he said Africa needs to look beyond vaccines and expand its target to medical equipment and local companies that are involved in their production across the continent.

“We need to identify more of these facilities, leverage the volumes, regionally, and the entirety of the continent, and look to see how we leverage those volumes, into our domestic manufacturing plants across the country. So we start establishing these economies of scale, and we grow from there,” he concluded.

Setting Priorities

Abderrahmane Maaroufi, Director of Morocco’s National Public Health Institute, noted that Africa’s stakeholders need to identify top priorities for medicine production, and set goals for the local vaccine production on the continent.

He said that Africa can prioritise vaccines like the human papillomavirus (HPV) vaccine that are complex and expensive globally, as well as vaccines against meningitis.

Maaroufi added that Africa should also prioritise vaccines to respond to the epidemiological threats of emerging diseases such as Ebola and rabies.

“And the reason I say this is because these kinds of products are very expensive, on a global level. It’s very hard to buy them because the demand is low and are limited to a few countries,” Maaroufi said.

Notably, Maaroufi added that Africa can also focus on improving the local production of anti-snake venom and similar treatments that are specific and peculiar to Africa.

“We need to prioritize this kind of production which is very specific to the scorpions and other serpents that exist in our continent,” he added. 

Dr Amadou Alpha Sall, Director of the Institut Pasteur de Dakar in Senegal

Africa needs to be able to produce up to 200 million doses of COVID-19 vaccine, according to Dr Amadou Alpha Sall, Director of the Institut Pasteur de Dakar in Senegal.

He noted that new technology could accelerate the pace towards closing the wide gap that exists in Africa’s vaccine manufacturing landscape.

“This action-oriented approach is something that we learn not only from the vaccine perspective but also we’ve learned from the diagnosis process,” he said.

Sall was referring to the $1 COVID-19 test kits that were developed by the Institut Pasteur de Dakar in collaboration with the British biotechnology company Mologic and the IRD, the French National Research Institute for Sustainable Development.

He added that Africa also needs to figure out long-term funding and identify partners that will commit to the venture for a long-term.

“It’s not just about putting money on a regular basis but also about building business models that are very relevant to Africa,” he added.

He opined that attention should be focused on Africa’s peculiarities—putting into consideration the continent’s specificity in order to identify the unique business model that would be financially sustainable and at the same time make high quality products with affordable access. 

“These would be something that is critically important and that’s where the value of partnership is important. We need to put together a great foundation that will support these initiatives while at the same time, mobilizing some domestic funds,” he added.

Despite the enormous tasks ahead, Sall said the coordination of the African Union through the Africa CDC could and should enable the continent to achieve the set goals. 

“With the coordination through platforms and hubs, we can build in different regions, capacity to be involved. To provide vaccines to everybody seems to be critical to coordination is really key,” he added.

WTO to Prevent ‘Vaccine Hoarding’

Ngozi Okonjo-Iweala, Director-general of the World Trade Organization (WTO), told the conference that the organisation intends to create a framework to prevent “vaccine hoarding” in future pandemics.

She also revealed that the WTO will hold a meeting this week with vaccine manufacturers to discuss trade barriers and how to increase the production of COVID-19 vaccines.

This initiative comes as the effort by India and South Africa to get pharmaceutical manufacturers to waive their intellectual property rights to COVID-related medicines and products, appears to have stalled. 

In the weeks leading to the conference, Health Policy Watch reported stakeholders in public health on the continent warned against vaccine wars and expressed worry regarding the fate of Africa which they said is a victim of an unfair distribution of the already approved COVID-19 vaccines. 

While countries in the Western world have more than enough doses for their citizens, African countries that got some doses of vaccines through COVAX Facility are already running out of supplies and developments elsewhere, including in India, suggested they may not get additional doses anytime soon.

“The current COVID-19 pandemic presents a great opportunity to harness the various conversations and proposals into an action-oriented roadmap led by the African Union and the World Health Organization (WHO) in Africa. And this will lead to increased vaccine production that will facilitate immunization of childhood diseases and enable us to control outbreaks of highly infectious pathogens,” said William Kwabena Ampofo, Chairperson of African Vaccine Manufacturing Initiative.

Naoko Yamamoto, WHO’s Assistant Director-General for Universal Health Coverage and Healthier Populations

Although taxing tobacco products is one of the most effective ways to discourage smokers – and it provides governments with revenue – it is “the least implemented” tobacco control policy globally, according to the World Health Organization (WHO).

“It takes vision and courage for political leaders to stand up against the powerful vested interests that profit from tobacco,” said WHO Director General Dr Tedros Adhanom Ghebreyesus at Monday’s launch of a manual on tobacco tax administration aimed at helping governments to levy taxes.

Tobacco use accounts for an estimated eight million deaths a year, but only 38 countries covering 14% of the global population had sufficiently high tobacco taxes in 2018, according to the WHO. 

“Raising tobacco taxes so that they account for at least 70 percent of retail prices would lead to significant price increases, induce many current users to quit, and deter numerous youth from taking up tobacco use, leading to large reductions in the death and disease caused by tobacco use,” according to the WHO.

Highest Taxes in Sri Lanka

Sri Lankan Health Minister Pavithra Devi Wanniarachchi

Sri Lanka and Oman are amongst the handful of countries with high taxes – accounting for 70% and 64% of the price of cigarette packs respectively.

Sri Lankan Health Minister Pavithra Devi Wanniarachchi told the launch that her country  “proudly meets the highest level of achievement with regards to tobacco taxation on cigarettes”.

“We have increased this tax at regular intervals in order to effectively decrease the affordability, and therefore the consumption, of these deadly products,” said Wanniarachchi, but added that bidis and chewing tobacco also needed to be taxed at the same level as cigarettes as they were “just as deadly”.

Oman’s health minister, Ahmed Mohammed Obaid Al Saidi, told the launch that his country had raised taxes from 25% to 64% between 2018 and 2020 and expected this to have an impact on consumption although “smoking is very low” in Oman. 

Jeremias Paul, the WHO’s Coordinator of the Tobacco Control Economics Unit, said that the tobacco industry used scare tactics to dissuade governments from taxation, including claiming taxes were anti-poor, would cause job losses and result in court action.

He urged governments to prepare adequately to combat industry arguments, and that the manual would assist with this.

Young People Are Price- Sensitive

Young people are two to three times more responsive to taxes and price than older persons, thus “higher taxes and prices are particularly effective in keeping young people from moving beyond experimentation with tobacco use, preventing them from becoming regular and, eventually, addicted users”, according to the manual.

It guides readers through the steps necessary to create strong tobacco taxation policies, including practical pointers on how to navigate through the political process and win support for taxes.

In the “best practice” chapter, the WHO urges governments to use the tax revenue to address the health problems caused by tobacco, implement a simple excise tax, tax all tobacco products in a similar way to avoid consumers moving from one product to another and eliminating duty-free sales.

Where the tobacco industry has threatened job losses, “using a portion of new tobacco tax revenues to move tobacco farmers into other crops or to retrain those employed in tobacco product manufacturing for work in other sectors would significantly reduce these concerns”.

Naoko Yamamoto, WHO’s Assistant Director-General for Universal Health Coverage and Healthier Populations, said raising taxes “is particularly timely in the context of a COVID-19 recovery where countries face large budgetary pressure”. 

“Improved tobacco tax policy can be a crucial component of building for better,” said Yamamoto.

Dr. Maria Van Kerkhove, WHO Technical Lead on COVID-19, at the press conference on Monday.

The World Health Organization (WHO) has called for a global “reality check” as COVID-19 infections increased by 4.4 million in the past week, with countries and individuals abandoning proven methods to protect themselves.

“This is not the situation we want to be in 16 months into a pandemic, where we have proven control measures. It is time right now where everyone has to have a reality check about what we need to be doing,” Maria van Kerkhove, WHO’s COVID-19 Technical Lead, told the global body’s bi-weekly media briefing.

Van Kerkhove warned that the world was in a “critical point of the pandemic,” which is “growing exponentially.”

WHO Director General Dr Tedros Adhanom Ghebreyesus blamed “confusion, complacency and inconsistency in public health measures” for the increases, pointing to “several countries in Asia and the Middle East that have seen large increases in cases.”

India, Turkey, Iran, the Philippines and Iraq are driving these regional increases.  

“Make no mistake, vaccines are a vital and powerful tool, but they are not the only tool,” stressed Tedros. “We say this day after day, week after week, and we will keep saying it: physical distancing works, masks work, and hygiene works. Ventilation works, surveillance testing, contact tracing, isolation, supportive quarantine and compassionate care all work to stop infections and save lives.”

Tedros pointed to the fact  that in some countries with high transmission rates “restaurants and nightclubs are full, markets are open and crowded with few people taking precautions.”

He also warned young people not to assume that they could not get seriously ill, pointing to the deaths of young, healthy people and the effects of ‘long COVID.’

“Many people who have suffered even mild disease report long term symptoms, including fatigue, weakness, brain fog, dizziness, tremors, insomnia, depression, anxiety, joint pain, chest tightness and more, which are symptoms of long COVID,” warned Tedros.

Dr Tedros Adhanom Ghebreyesus, WHO Director General.

“This is exactly the time where we need to double down on the non-pharmaceutical interventions, on masking and reducing transmission, because we give the vaccines their best chance of providing protection,” said Kate O’Brien, WHO’s Director of Vaccines. “When, in addition to scaling up immunity through vaccination, we reduce transmission, this reduces the likelihood of having [the] emergence of variants.”

Van Kerkhove urged people to “check their social media feeds” to see “what people are doing and how you are mixing” to keep safe.

Vaccine Supply is ‘Precarious’

Bruce Aylward, WHO’s lead at COVAX, admitted that the “whole vaccine supply situation remains precarious,” and the challenge of managing community was “very difficult one to manage.”

India continued to make “tremendous demand” on the supply of AstraZeneca vaccines being produced by the Serum Institute of India.

This vaccine is the backbone of COVAX and requires two doses but the interval between doses could be extended to 12 weeks, said Aylward. 

“Obviously we’d like to make sure that that interval doesn’t go longer than that so we’re doing everything possible to ensure the supply of AstraZeneca’s product in particular because that’s what’s gone out,” said Aylward. 

Vaccine Manufacturing Task Force

The WHO’s Chief Scientist, Soumya Swaminathan, clarified that the Vaccine Manufacturing Task Force being set up under COVAX was focused on the “immediate removal of any obstacles” to vaccine rollout.

At present, it was focused on “raw materials and ingredients and the tubings and the plastic, which is getting into short supply,” she said.

Dr. Soumya Swaminathan, WHO Chief Scientist.

“There are also export restrictions that have been put in place by some countries on some of these products, which is creating a problem for some manufacturers,” added Swaminathan. 

“The first step is really to identify what those critical needs are, where there is a global supply shortage and try to address them, but also work with governments to make sure that there are no export restrictions. That’s where the World Trade Organization (WTO) and the trade rules would come in.”

Earlier in the day, the WTO’s new Director General Dr Ngozi Okonjo-Iweala, told an African manufacturing conference that the trade body planned to introduce rules to prevent hoarding during pandemics.

Image Credits: Mohsen Atayi, WHO.

Previous SARS-CoV2 infection conferss a high degree of protection, according to a new study.

Previous infection with SARS-CoV2 induces effective immunity against future infections by 84% – but reinfection rate is still 16%, found a study published in The Lancet on Friday. This suggests that infection-induced immunity is similar to, or greater than, vaccine-associated immunity, said the authors. 

The SARS-CoV2 Immunity and Reinfection Evaluation (SIREN) study involved 25,661 health workers in the UK and took place between June 2020 and January 2021. 

It was conducted by researchers at Public Health England, and the Universities of Oxford, Bristol and Cambridge.

Participants were separated into a positive cohort – based on antibody positive or previous positive PCR tests – and a negative cohort – antibody negative or no previous positive PCR test.

Questionnaires on symptoms were sent to participants and diagnostic testing was conducted every two weeks, and antibody testing took place every four weeks. Reinfection was defined by the researchers as a participant with two positive PCR tests 90 or more days apart or an antibody-positive participant with a positive PCR test. 

Some 155 reinfections were detected in the positive cohort of 8,278 participants and 1,704 new infections were identified in the negative cohort of 17,383 participants. The interim results from the study showed that previous infection reduced reinfection by at least 84%.

 

Weekly frequency of study participants with a positive PCR test result by cohort assignment, from March 2020, to January 2021.

 

Approximately 50.3% of the reinfections were symptomatic, with 32.3% of those having typical COVID-19 symptoms, which include cough, fever, and loss of taste or smell. The average interval between primary infection and reinfection among participants was 201 days.

The lowest level of protection against reinfection was provided to asymptomatic infection, with 76 of the 155 participants with reinfection having asymptomatic reinfection.

Vaccines and Variants

During the study period, 52.2% of the participants were vaccinated, however, the authors said that the findings on the durability of protection following their previous infection were independent of the vaccine effect. 

The researcher recommended that future studies examine the protective effect of both previous infections and vaccine efficacy. 

In addition, the B.1.1.7 variant had spread rapidly during the study period causing over 50% of the infections among participants. Despite the circulation of the more transmissible variant, the study found no evidence that the spread of the variant adversely impacted reinfection rates. 

This shows that immunity from a previous infection from a different SARS-CoV2 strain is still protective against the variant. 

Comparable Protection from Infection and Vaccines, Say the Authors

“Our findings…show equal or higher protection from natural infection, both for symptomatic and asymptomatic infection [compared to vaccines],” said the authors. 

The protection against asymptomatic reinfection is particularly important to reduce the risk of onward transmission.

Although the Pfizer/BioNTech and Moderna COVID-19 vaccines were 90% effective against PCR-confirmed infection, according to a study conducted by the US Centers for Disease Control and Prevention (CDC) in early April, natural infection induces a wider range of immune responses. 

Antibodies induced by infection are often lower in concentration compared to antibody responses induced from vaccinations, but can include responses beyond the spike protein, which is the target of current vaccines, said Florian Krammer, Professor of Microbiology at the Icahn School of Medicine at Mount Sinai in New York, in a comment to the study. 

This study is “valuable to understand the nature and duration of protective immunity,” said Soumya Swaminathan, WHO Chief Scientist, on Twitter. 

Further studies on the longevity of antibody responses, reinfection with the new SARS-CoV2 variants, and the impact of the existing vaccines on reinfection are reportedly underway.

Image Credits: Flickr – International Monetary Fund, The Lancet.

The Johnson & Johnson COVID-19 vaccine.

The European Medicines Agency is reviewing the cases of four people who developed blood clots after receiving Johnson & Johnson’s (J&J) COVID-19 vaccine, the regulator announced on Friday. 

“Four serious cases of unusual blood clots with low blood platelets have been reported post-vaccination with COVID-19 Vaccine Janssen. One case occurred in a clinical trial and three cases occurred during the vaccine rollout in the USA. One of them was fatal,” the regulator said in a statement after a meeting of its Pharmacovigilance Risk Assessment Committee (PRAC) ended on Friday.

The vaccine is currently being used in the USA under an emergency use authorisation, and in South Africa as an implementation trial to vaccinate health workers.

It was authorised in the EU on 11 March and member states were expected to start rolling it out in the next few weeks. 

“These reports point to a ‘safety signal’, but it is currently not clear whether there is a causal association between vaccination with COVID-19 Vaccine Janssen and these conditions,” said the EMA. “PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information.”

PRAC is also investigating a bleeding disorder linked to AstraZeneca. 

“Five cases of this very rare disorder, characterised by leakage of fluid from blood vessels causing tissue swelling and a drop in blood pressure, were reported in the EudraVigilance database,” according to the EMA, although it said no causal relationship had been established between the condition and the vaccine.

PRAC has also concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of AstraZeneca.

Both AstraZeneca and Johnson & Johnson vaccines use the same viral vector technology. 

Image Credits: Johnson & Johnson.