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Russian vaccine rejected over concerns that adenovirus can reproduce; US discusses waiver of IP rights to fight pandemic
Vaccines dominate this week’s Phispers as governments across the world evaluate jabs from various manufacturers and look at ways to curtail the pandemic. In the US, trade representative Katherine Tai discussed a proposed waiver of certain intellectual property rights with vaccine makers Pfizer and AstraZeneca, and Moderna entered into an agreement with Sanofi to make its Covid-19 vaccine.
While Brazil rejected Russian vaccine Sputnik V, three Chinese companies have signed agreements with the Russian Direct Investment Fund to produce 260 million doses of the Russian vaccineper annum.
After suspending the J&J vaccine on April 13, the US has lifted the ban on the single-dose jab. With the country having an ample supply of vaccines, the Biden Administration has discontinued funding for the phase 3 segment of the Innovate trial. As a result, American biotech Inovio plans to hold phase 3 trials of its experimental jab outside of the US.
The European Union has sued AstraZeneca over failed deliveries of its vaccine and is working towards securing additional doses of the Pfizer and Moderna jabs.
The Biden Administration said the US will begin sharing its entire stock of AstraZeneca Covid-19 vaccines with the world once it clears federal safety reviews. With this move, as many as 60 million doses may become available. India, which is in the midst of a devastating second wave, hopes to get a large chunk of these doses. And Merck has partnered with five Indian drugmakers to boost production of its experimental Covid drug — molnupiravir.
Brazil rejects Sputnik V due to presence of adenovirus that could reproduce
A few weeks back, Brazilian drugs regulator Anvisa had rejected Indian drugmaker Bharat Biotech International’s application for supplying Covaxin to Brazil after an inspection of the company’s facility at Hyderabad in March found violations of good manufacturing practices norms. This week, Anvisa has rejected a similar application for importing Russian-made Sputnik V.
A crucial issue for Anvisa was the presence of the adenovirus in the vaccine that could reproduce, which is a “serious” defect, according to Anvisa’s medicines and biological products manager Gustavo Mendes.
In the case of Bharat Biotech too, Anvisa said the Indian drugmaker has not validated the method used to inactivate, or kill, the virus, which may cause contamination of patients with the SARS-CoV2 virus itself.
Ana Carolina Moreira Marino Araujo, general manager for health monitoring, said considering all the documentation presented, data acquired at in-person inspections and information from other regulators, “inherent risks” (in the case of Sputnik V) were too great.
The Russian Direct Investment Fund (RDIF), which markets the Sputnik V vaccine abroad, rejected Anvisa’s comments, saying the vaccine’s safety and efficacy had been assessed by regulators in 61 countries which approved it for use.
According to the slides translated from Portuguese, “the developers have failed to provide enough data to back up their claims of efficacy and have left a string of open questions about the vaccine's development.”
“The adenovirus in Covid vax is not supposed to replicate (it’s supposed to be just a carrier),” health consumer advocate Hilda Bastion said on Twitter.
In March-end, Slovakian Prime Minister Igor Matović had to resign amid a political scandal triggered by a secret deal to buy the Russian vaccine. Earlier this month, Slovakia’s drug regulator said the composition of a batch of Russia’s Sputnik V vaccine delivered to Bratislava could not be verified.
“Batches of (Sputnik V) vaccine used inpreclinical tests and clinical studies published in the Lancet journal do not have the same characteristics and properties as batches of vaccine imported to Slovakia,” the State Institute for Drug Control (SUKL) said in a statement.
Chinese companies to produce 260 million doses of Sputnik: Over the past three weeks, three Chinese drug companies have signed agreements with RDIF to produce a total of 260 million doses per annum of Sputnik V.
If these companies successfully deliver the foreign-developed vaccine on a massive scale, the “made in China, for the world” model could gain momentum and make the country a production base of global vaccines to fight the coronavirus, experts said.
US trade rep meets top execs of Pfizer, Astra to discuss waiver of IP rights to fight pandemic
In December, South Africa and India had called for the World Trade Organization (WTO) to waive certain provisions of Trade-Related Aspects of Intellectual Property Rights (TRIPS) related to Covid-19 to ensure that lower income and middle income countries are able to access and afford the vaccines, medicines, and other new technologies needed to control the pandemic. At that time, the drug industry, and many high-income countries (HICs) had strongly opposed the move saying that it will stifle innovation.
Since then, several countries have backed India and South Africa’s proposal and the US has faced mounting pressure to back a temporary waiver of IP rights to accelerate Covid-19 vaccinations around the world. In the US, democratic lawmakers, civil society groups, 60 former heads of state and 100 Nobel Prize winners have urged President Joe Biden to back the waiver.
This week, US Trade Representative Katherine Tai had a virtual meet with top executives of Pfizer and AstraZeneca to discuss the matter.
While the US and other big countries have blocked a move by the members of the WTO to discuss the proposal put forth by India and South Africa on April 30, Tai’s meeting with the Pfizer and AstraZeneca executives reflect her intense engagement on the issue. Earlier this month, Tai had said at a WTO meeting that the gaping divide between developed and developing countries’ access to medicines was “completely unacceptable” and that the industry needed to make sacrifices in times of crisis.
Sanofi to make Moderna’s jab: In October 2020, Moderna had issued a statement wherein it said that it will not enforce its Covid-19 related patents against those making vaccines intended to combat the pandemic. “Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for Covid-19 vaccines to others for the post pandemic period,” Moderna had said.
In line with that statement, Moderna has entered into an agreement with Sanofi under which the French drugmaker will help manufacture Moderna’s Covid-19 vaccine.
Beginning September, Sanofi will leverage its infrastructure and expertise at its site in Ridgefield, New Jersey, to perform fill and finish of up to 200 million doses of Moderna’s Covid-19 vaccine.
This marks Sanofi’s third commitment to provide manufacturing support during the pandemic, which includes agreements it has signed with BioNTech, J&J and GSK.
Merck partners with five Indian drugmakers to boost production of its experimental Covid drug
India, which is witnessing a cruel second wave of the pandemic with over 350,000 cases being reported every day, is seeing some action on the production of Covid drugs. Merck said this week it has partnered with five Indian generic drugmakers, including Cipla and Sun Pharma, to expand production and access to its experimental Covid-19 drug — molnupiravir.
Merck has also signed non-exclusive production pacts for molnupiravir with Dr Reddy's Laboratories, Emcure Pharmaceuticals and Hetero Labs.
Molnupiravir is an antiviral therapy that Merck is developing with Ridgeback Biotherapeutics for the treatment of non-hospitalized Covid-19 patients. It is currently under Phase 2/3 trials.
The partnership will give these companies license to supply Merck’s molnupiravir to India and over 100 low and middle income countries following approvals or emergency authorization by local regulatory agencies, Merck said.
Gilead to donate 450,000 remdesivir vials to India: During the raging second wave, India has been facing an acute shortage of remdesivir. To overcome this shortfall, Gilead Sciences announced it is donating 450,000 vials of its antiviral drug, remdesivir, to India. The drugmaker also said it will provide technical assistance to its seven Indian licensees so they can expand production capacity for remdesivir and donate active pharmaceutical ingredients (APIs).
US lifts ban on J&J’s vaccine; Inovio plans Phase 3 trial of its jab outside US as govt scuttles funding
Late last week, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) lifted the pause on Johnson & Johnson’s Covid-19 vaccine after deciding that a very rare but sometimes fatal side effect does not change the fact that the vaccine’s benefits still outweigh the risks. The Janssen Covid-19 vaccine is recommended for those 18 years and above in the US under the FDA’s emergency use authorization.
The agency also updated the factsheets to include the risk of blood clots and low levels of platelets, known as thrombosis with thrombocytopenia syndrome (TTS).
The CDC has spotted 15 cases of TTS, among 8 million recipients of the vaccine. The 15 cases include three deaths and seven hospitalizations. Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office, also said about 10 other possible cases of TTS are under investigation.
A day prior to the lifting the ban on the J&J vaccine, there was news that frustrated senior health officials have largely written off the shot, a report published in Politico said.
Though J&J has a long history of successes in vaccine development, it has faced several setbacks with its one-dose Covid vaccine, including the contamination of 15 million doses at its contractor Emergent BioSolutions’ plant in Baltimore. According to the news report, the chaos has disappointed the Biden team.
Meanwhile, the US government has decided to discontinue funding for the Phase 3 segment of the Innovate trial, while continuing to fund the completion of the phase 2 segment. The move comes as a result of the growing availability of vaccines in the US that have been authorized for emergency use.
As a result, American biotechnology firm Inovio has announced it is planning for a predominantly ex-US Phase 3 trial for its Covid-19 vaccine candidate — INO-4800. INO-4800 is a DNA vaccine.
EU sues Astra over failed deliveries; secures additional doses of Pfizer, Moderna jabs
The European Union has initiated legal action against AstraZeneca for not respecting its vaccine supply contract, and for not having a “reliable” plan to ensure timely deliveries.
A European Commission spokesman said the action was launched on Friday, with the backing of all 27 member states. It stems from a contract the commission signed in August 2020 to secure 300 million doses for the EU by the end of June, with an option for an additional 100 million doses.
Earlier this year, AstraZeneca said its supplies would be reduced because of production problems. Of 80 million doses planned for delivery in the first quarter of 2021, only about 30 million were sent. According to the European Commission, the company will provide 70 million doses in the second quarter of 2021 instead of the 180 million.
AstraZeneca said the move was “without merit” and it would “strongly defend itself in court”. Some in the bloc have also alleged that AstraZeneca has shown preferential treatment to the UK.
Meanwhile, the European Medicines Agency (EMA) is working to secure additional doses of the Covid-19 vaccine developed by Pfizer-BioNTech with an aim to deliver 1.8 billion doses to Europe by the end of 2023.
EMA has approved Pfizer’s Puurs (Belgium) facility for boosted manufacturing capacity. EMA’s Committee for Medicinal Products for Human Use (CHMP) has also recommended approving a new filling line for Moderna’s messenger RNA Covid-19 vaccine plant in Rovi, Spain.
Israel probes heart inflammation cases linked to Pfizer’s jab: In Israel, health officials are investigating cases of inflammation of the heart, post getting the Pfizer vaccine. Israel has witnessed dozens of cases where people have experienced heart inflammation after receiving the Pfizer-BioNTech’s Covid-19 shot. The vaccine has been given to more than 5 million people, Corona Commissioner Nachman Ash said.
The Israel government has identified 62 incidents of inflammation of the heart muscle, or heart-muscle membrane. The condition developed in one out of 100,000 people who received the shot. The incidence rate for men between the ages of 18 and 30 years was one in 20,000. Two people have died, while the rest have recovered from the condition.
Pfizer is aware of the Israeli cases of myocarditis, the company said in a statement. While health officials are investigating whether the cases are connected with the shot, Pfizer has denied the existence of a causal link to the vaccine. “We have not observed a higher rate of myocarditis than what would be expected in the general population,” Pfizer said.
US to share vaccine supply; India to secure biggest chunk of its 60 million Astra doses
As India experiences devastating surges of the virus and other countries struggle to access vaccine doses to protect their vulnerable populations, the US has come under pressure to share more of its vaccine supply with the world.
This week, the Biden Administration said that the US will begin sharing its entire stock of AstraZeneca Covid-19 vaccines with the world once it clears federal safety reviews. With this move, as many as 60 million doses are expected to be available for export in the coming months. Last month, the US had said it would share about 4 million doses of the vaccine with Mexico and Canada.
The AstraZeneca vaccine is yet to bag emergency use authorization by the US Food and Drug Administration (FDA). With the resumption of the J&J vaccine over the weekend, the White House is feeling increasingly assured about the supply of the three vaccines being administered in the US.
About 10 million doses of AstraZeneca’s vaccine are with the US that are yet to pass review by the FDA. The White House said 10 million doses could be cleared for export “in coming weeks”.
Additionally, about 50 million doses are in various stages of production and could be available for export in May and June, pending FDA sign-off.
While the US is yet to finalize where the AstraZeneca doses will go, India expects to secure the biggest chunk of the 60 million Astra vaccines, a Reuters report said.
An official said India was lobbying hard to get more than 35 percent of the AstraZeneca doses. There was also news that the US is sending supplies worth more than US$ 100 million to India to help the country fight a huge surge in Covid cases.
The supplies will begin arriving on April 29 and will include 1,000 oxygen cylinders, 15 million N95 masks and 1 million rapid diagnostic tests, the statement said. The US has also redirected its own order of AstraZeneca manufacturing supplies to India, which will allow it to make over 20 million doses of the Covid-19 vaccine.
Apart from the US, India has been promised critical supplies by the UK, France, Ireland, Germany, Romania, Luxembourg, Switzerland, Sweden, Finland, Australia, New Zealand, Canada, Kuwait, the UAE, Mauritius, Saudi Arabia, Thailand and Singapore to fight the pandemic.
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