PVC’s Memorandum to Pharmaceuticals and J&J’s Response

Posted April 16, 2021

PVC’s Memorandum to Pharmaceuticals and J&J’s Response

This Memorandum, concerning patents and related issues threatening vaccine access, was delivered by the People’s Vaccine Campaign via email to Pfizer Inc, BioNTech, Johnson & Johnson, AstraZeneca, Moderna Therapeutics, Aspen Pharmacare on the 10th of March; with delivery by hand attempted on the 11th of March to Pfizer, J&J and AstraZeneca centres in SA (#With Pfizer refusing to accept the memorandum).
The letter can be read in full here: shorturl.at/cjpT6

Following this, on the 17th of March, PVC received a reply from J&J (*No replies from any other companies have been received)
This reply can be read in full here: shorturl.at/deuD8

[The PVC Memorandum & J&J Reply are reproduced in full below]

PVC-SA Memorandum

10 March 2021

Delivered by email & hand

URGENT

Pfizer Inc

Dr Albert Bourla

albert.bourla@pfizer.com

BioNTech

Dr Uğur Şahin

Media@biontech.de

Johnson & Johnson

Mr. Alex Gorsky and Abeda

Williams agorsky@its.jnj.com

Awillim1@its.Jnj.com

AstraZeneca Mr. Pascal Soriot

pascal.soriot@astrazeneca.com

Moderna Therapeutics

Mr. Stéphane Bancel

Stephane.Bancel@modernatx.com

Aspen Pharmacare Dr

Stephen Saad

ssaad@aspenpharma.com

The People’s Vaccine Campaign of South Africa (PVC-SA) calls on your company to drop patents and other intellectual property protections to end Vaccine Apartheid – we are in a pandemic.

We are the People’s Vaccine Campaign of South Africa (PVC-SA), formed to ensure that there is just, fair, and equitable access to COVID-19 vaccines.

The PVC-SA was launched in mid-January 2021 through a publicly-issued Call to Actioniand endorsed by over 190 organisations and 380 individuals. The first PVC-SA assembly was held on 13 February 2021.ii

11 March 2021 marks one year since the WHO declared Covid-19 a pandemic.iii As at 5 March 2021, 2 560 995 people died from Covid-19 in the world with 115 094 614 confirmed cases. Health care and other

front-line workers around the world have held up struggling health systems and persevered to save lives. They themselves have also faced enormous loss. At least 17 000 care workers have died from Covid-19 and urgent vaccine access is now needed for all front-line workers.iv Yet, as at 5 March 2021, the WHO reports that only 249 437 147 vaccine doses have been administered.v

The first case of COVID-19 in South Africa was announced on 5 March 2020,vi and as at 8 March 2021, there have been 1 521 706 cases and 50 803 deaths.vii To date, less than 60 000 HCWs have been vaccinated – and only as part of a study.

In 2020, unprecedented accelerated vaccine research was carried out through substantial public investment and co-funding, with the pioneering research work of many clinicians, scientists, laboratory researchers and volunteers around the world, including by some of your companies, and in our country. There are now several promising vaccines available for human use and in turn, for immunisation programmes even where variants have been discovered. Our best chance of ending this pandemic is to ensure that everyone, everywhere has access to Covid-19 vaccines, tests, and treatments. However, unfortunately, the widespread rollout of vaccines has been beset by many problems.

The South African government has also indicated in recent court papers, on oath, that it is negotiating with your company to secure vaccine supplies for people living in South Africa (and elsewhere on the continent) whilst regulatory approval is being fast-tracked.

But, despite the devastating impact of the pandemic, there continues to be very limited sharing of knowledge and know-how at a time when the world faces an acute shortage of vaccines and when millions of people are becoming sick and dying.

Your company and others can act now to change that by removing restrictions on technology transfer and knowledge-sharing and opening up licenses to as many manufacturers as possible while also not opposing the temporary TRIPS waiver request at the WTO.

Your companies now hold the health and survival of the world’s population in your hands, and your willingness to act for the public good, will be difference between life and death for millions of people.

We therefore call on your company to:

Immediately and openly share technological know-how with manufacturers globally, including manufacturers in developing countries; and
Instill greater transparency and accountability in your dealings with the government of South Africa (which uses public resources to pay for vaccines).

Or – please explain to the public in South Africa, why you refuse to do so, and be held accountable.

Specifically, we also want to establish why your company is not committing to ramping up manufacturing globally, with multiple partners, including through C-TAP, during this pandemic.

Second, you cannot use commercial secrecy arguments to undermine democratic oversight by institutions in our country or to suppress media scrutiny. Such secrecy is anti-democratic, immoral, and unconstitutional.

We remain particularly concerned at reports that your company refuses to answer journalists questions in our country; that you are unwilling to engage civil society, trade unions, faith organisations and other interested parties on pricing and other related concerns that require greater transparency; that your negotiations with the government in South Africa demands non – disclosure agreements and secrecy; and that you are compelling South Africa and other countries to provide no-fault indemnity schemes. These business practices are unfair, unconscionable and an affront to transparency in an open and democratic society, especially during a pandemic.

In particular:

PRICING: Price lists and pricing data have not been fully and publicly shared by vaccine companies such as yours, and it has since emerged that differential and higher prices are being charged indiscriminately for the same vaccine, across countries and across purchasing mechanisms (including COVAX) and among a handful of sub-licensees.
The price of all vaccines and all agreements must be publicly disclosed as currently AstraZeneca/Oxford University and its sub-licensees (Serum Institute for India and SK BioScience) are charging different prices for its vaccine despite committing to a low or no profit pledge without adequate explanations from any / all of the companies involved.
LICENSES: There is insufficient transparency about the number and also terms and conditions of any full or partial voluntary licenses (if any) issued by your company, especially as it relates to pricing and market segmentation and / or market restrictions on supplies. There is also no explanation being offered as to why you are refusing to grant multiple manufacturing or fill and finish licenses.
For example, Johnson & Johnson has only issued a fill and finish sub-license to Aspen Pharmacare, not a full manufacturing license, and both companies remain secretive about which countries those supplies are destined for, and the price and quantities. Aspen and Johnson & Johnson must clarify the full terms of the licence; disclose what, if any, technology transfer arrangements are being discussed, and what negotiations are underway about future supplies of vaccines with the government of South Africa/others.

SA INDEMINITY WAIVER: Please indicate if your company has also requested a no-fault compensation scheme and / or liability indemnity or similar guarantees from the South African government, and why?
Will you also be demanding sovereign assets as a guarantee for civil claims (as Pfizer has done in South America), and in addition, how do you justify holding

countries to ransom in a pandemic?

TRIPS WAIVER: Is your company opposing the TRIPS Waiver request at the WTO, co sponsored by at least 57 countries and supported by the overwhelming majority of WTO members? Why?
In the absence of the waiver, or compulsory state measures, how does your company’s senior management and shareholders plan to address the moral and public health crisis brough about by vaccine apartheid, with its artificial supply shortages (also mainly created by your company)?
SA REGULATORY REVIEW: Has your company submitted a regulatory dossier for approval to SAHRPA, to inform South Africa’s vaccine selection – when? If not, why not? And if not, will sub licenses to other manufacturers be granted to enable them to do so– if not, why not?
PRIVATE SECTOR PROCUREMENT AND ALLOCATION OF VACCINES OUTSIDE OF A NAITONAL STRATEGY: Is your company negotiating with any private actors, businesses or the like, other than the South African government, to supply vaccines to South Africa, outside of a national equitable and public health allocation strategy, if yes, why?

We hope to hear from you with the necessary urgency. Failing which we will pursue all necessary steps to hold your company fully accountable for the full realisation of everyone’s health rights in our country, under the Constitution of the Republic of South Africa.

Sincerely,

The PVC-SA

peoplesvaccinecampaign@gmail.com

Endnotes

i https://c19peoplescoalition.org.za/towards-a-peoples-vaccine-campaign-a-call-to-action-abridged-version/ The PVC–SA endorses and supports global calls for a global People’s Vaccine and Free the Vaccine Alliance so that everyone, everywhere can access a vaccine, free of charge. In January 2021, the Archbishop of the Anglican Church of Southern Africa on behalf of the PVC SA wrote an Open Letter to Dr Tony Fauci and others requesting the new US President to step in to ramp up manufacturing capacity, especially of vaccines that it has co-developed and co-funded.

iii https://www.euro.who.int/en/health-topics/health-emergencies/coronavirus-covid-19/news/news/2020/01/2019-ncov-outbreak-is an-emergency-of-international-concern; https://www.who.int/director-general/speeches/detail/who-director-general-s-opening remarks-at-the-media-briefing-on-covid-19—

11-march-2020

iv https://uniglobalunion.org/news/covid-19-health-worker-death-toll-rises-least-17000-organizations-call-rapid-vaccine-rollout vhttps://covid19.who.int/

viFirst case of COVID-19 reported in SA, 5 March 2020, https://www.nicd.ac.za/first-case-of-covid-19-coronavirus-reported-in-sa/ vii COVID-19 Statistics in South Africa, 8 March 2021 https://sacoronavirus.co.za/category/press-releases-and-notices/

The People’s Vaccine Campaign of South Africa (PVC-SA)

Peoplesvaccinecampaign@gmail.com

17 March 2021

Dear Sir / Madam

Response to the PVC-SA Memorandum dated 10 March 2021

Thank you for reaching out to Johnson & Johnson with this matter.

Johnson & Johnson is committed to enabling equitable global access to the investigational Janssen COVID-19 vaccine candidate on a not-for-profit basis for emergency pandemic use, if approved for use by local health authorities. As part of this commitment, we recognize the importance of ensuring that people in Africa have timely access to our vaccine. We have pledged to provide up to 500 million vaccine doses to lower income countries, with delivery to begin in mid-2021. In December 2020, we reached an agreement in principle with Gavi, the Vaccine Alliance, in support of the global COVAX Facility, to help deliver on this commitment.

Additionally, Janssen Pharmaceutica NV, one of the pharmaceutical companies of Johnson & Johnson, has entered into an agreement with the Government of the Republic of South Africa to supply 11 million doses of its COVID-19 vaccine candidate. Currently, there is a rolling submission with the South African Health Products Regulatory Authority, which was initially submitted in December 2020.

To support the Janssen COVID-19 vaccine, we have forged new manufacturing partnerships with multiple companies across three continents. Each of these partnerships include a license to our technology and the sharing of manufacturing know-how to enable the safe and high-quality production of our vaccine and to activate our manufacturing on a global scale as soon as possible. Our collaboration with Aspen Pharmacare, based in South Africa, completes one step in this complex, global process. To ensure the fastest and most equitable delivery of our vaccine to the world, it is critical for countries to allow the free movement of our vaccine once approved.

We have been able to quickly respond to the COVID-19 pandemic because of research and science supported by a reliable intellectual property system, as well as through our collaboration with multiple global partners. After this pandemic is over, intellectual property will continue to play a pivotal role in addressing the healthcare challenges of tomorrow. We do not believe that intellectual property is a barrier to the development of, or access to, COVID-19 treatments and vaccines. To the contrary, our experience shows that intellectual property is playing an essential role in the rapid development of innovative solutions to address this crisis.

We remain at your disposal should you require any clarity.

Kind regards,

Abeda Williams

Senior Director Medical Affairs

Johnson & Johnson Global Public Health