Vaccine cocktails in the works: UK, China, France consider mixing jabs; India bans exports of remdesivir

Vaccine cocktails in the works: UK, China, France consider mixing jabs; India bans exports of remdesivir

By PharmaCompass

2021-04-15Impressions: 1622

Vaccine cocktails in the works: UK, China, France consider mixing jabs; India bans exports of remdesivir

This week, Phispers brings you a host of trends from across the globe pertaining to Covid vaccines. Countries like the UK, China and France are talking about mixing vaccines to boost their efficacy. After AstraZeneca, Johnson & Johnson’s single-dose Covid jab faced concerns over safety as six women in the US suffered rare blood clots after getting the shot.

India, which has been witnessing a steep rise in Covid-19 cases, has decided to stop exports of the antiviral drug, remdesivir. With several Indian drugmakers seeking an emergency nod from the country’s drug regulator to manufacture remdesivir off-license, the government has approved ramping up remdesivir’s production from 3.88 million to around 7.8 million vials per month.

In a bid to step up its inoculation program, the Indian government has also decided to fast-track emergency approvals for Covid vaccines that have been produced in other countries. The country has also approved Russia’s Sputnik V.

Meanwhile, Sanofi has decided to invest US$ 475 million in setting up a cutting-edge mRNA vaccine manufacturing plant in Singapore, after announcing an investment of US$ 715 million in buying a flu shot factory in Toronto last month. The company is buying Massachusetts-based biotech Tidal Therapeutics, which is developing messenger RNA-based treatments for cancer.

Meanwhile, the FDA has named Patrizia Cavazzoni as the director of its Center for Drug Evaluation and Research, even as Janet Woodcock’s leadership at the agency remains unconfirmed.

Vaccine cocktails in the works: UK, China, France consider mixing jabs for better protection

Covid-19 vaccines are witnessing a new trend — the UK, France and China are contemplating administering a cocktail of vaccines to better protect their citizens.

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
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In the UK, a major study being led by the University of Oxford — the Com-Cov study — investigates alternating doses of the AstraZeneca and Pfizer vaccines for the first and second dose. The study, which was initiated in February this year, is examining whether Covid vaccines can be safely mixed with different types of jabs for the first and second doses. The scope of this study will now be expanded to include the Moderna and Novavax vaccines. The purpose is to provide longer-lasting immunity against the virus and its new variants and offer more flexibility in the administration of vaccines.

Similarly, Chinas top disease control official has said the country is considering mixing Covid-19 vaccines as a way of further boosting vaccine efficacy. Chinese vaccines lag behind others, including Pfizer and Moderna, in terms of efficacy.

Giving people doses of different vaccines is one way to improve vaccines that dont have very high rates of protection,” Gao Fu, the director of the Chinese Centers for Disease Control and Prevention, said.

And last week, France said those under 55 years of age who received a first injection dose of the AstraZeneca vaccine should be given a different jab as a second dose. This ruling will affect over 500,000 people. And these people will now get the Pfizer or Moderna jab as a second dose.

Last month, the health authority in France had said the AstraZeneca vaccine should only be given to those aged 55 and above due to reports of blood clots.

‘South African variant more adept at breaking through Pfizer vaccine’: A study undertaken by a team of scientists from Israel’s Tel Aviv University and the Clalit healthcare organization has found the South African variant of the coronavirus to be more adept at breaking through” the Pfizer-BioNTech vaccine than other variants.

Israel is largely relying on the Pfizer shot to vaccinate its citizens. It is also using the Moderna vaccine, though minimally.

The team sequenced the swabs of 150 Israelis who tested positive for Covid-19 despite having been vaccinated. The study found the prevalence of the South African strain among vaccinated individuals to be eight times higher than its prevalence in the unvaccinated infected population. Though the number of such infections among the vaccinated was relatively small, the findings indicated that this variant was far more successful in getting through vaccinated individuals’ defenses than other strains.

The research has been posted online but has not been peer-reviewed yet. It also raises questions about Pfizers own study findings that in South Africa, despite the local strain being prevalent, the vaccine was 100 percent effective.

India fast-tracks nod for foreign-produced Covid jabs; bans exports of remdesivir

India has witnessed a sudden surge in Covid-19 infections, with the country recording over 200,000 cases on April 14. Many states have been facing a shortage of vaccines. As a result, the Indian government has decided to fast-track emergency approvals to Covid vaccines that have a clearance for restricted use from regulatory authorities in the US, the UK, the European Union and Japan, besides those listed by the World Health Organization.

As of today, India is inoculating its population over the age of 45 years with two vaccines — AstraZeneca’s shot being manufactured by the Serum Institute of India (Covishield) and domestic drugmaker Bharat Biotech’s Covaxin. A third vaccine — Russia’s Sputnik V — bagged the Indian government’s nod this week.

The move is significant as it may make several vaccines available, including those made by Pfizer, Novavax and Johnson & Johnson, in India. The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out any further.

According to a news report, Pfizer Inc said it would work towards bringing its vaccine to India after the government eased import rules. Pfizer had withdrawn its application in February.

With cases rising, India has also banned exports of Gilead Sciences’ antiviral drug remdesivir. The current total installed capacity of the seven manufacturers of remdesivir is 3.88 million vials per month. On Wednesday, the Indian government approved ramping up of remdesivir production to around 7.8 million vials per month. Earlier, the Indian drug industry had sought emergency approval to manufacture remdesivir.

Meanwhile, Gilead has decided to stop its Phase 3 Veklury (remdesivir) intravenous (IV) study in high-risk non-hospitalized patients with Covid-19, due to challenges in enrollments.

As India grants emergency nod to Sputnik V, Europe, Brazil evaluate it on clinical, ethical standards

This week, India granted emergency licensure to Russian vaccine Sputnik V. This is a major development for India, as it struggles to increase the supply of vaccines for its immunization program amid a sharp surge in Covid-19 infections. Sputnik V is now approved for use in 60 countries around the world.

As per an agreement between the Russian Direct Investment Fund (RDIF) and Hyderabad-based Dr Reddys Laboratories (DRL), India can now expect at least 200 million doses of Sputnik V.

Meanwhile, DRL has announced it has received permission from the Drug Controller General of India (DCGI) to import the Sputnik V into India for restricted use in emergency situations.

The price of the vaccine is expected to drop when Indian companies start producing the vaccine.

The efficacy of Sputnik V was determined to be 91.6 percent as per an article published in The Lancet, a weekly peer-reviewed general medical journal.

EU to probe ethical standards of Sputnik V: The European Medicines Agency (EMA) will soon send a team to Russia to evaluate the Sputnik V vaccine. The regulator will look into whether clinical trials of Russias Sputnik V Covid-19 vaccine followed global clinical and scientific guidelines, the Financial Times has reported.

The report cited unidentified people familiar with the EMA’s approval process as having expressed concern that the Sputnik V trials may not have met ethics standards. So far, the vaccine has not received an EMA approval for use in the European Union.

An inspection of a manufacturing site is a normal step in the context of the evaluation of any marketing authorization application in the EU,” the EMA said.

In fact, Sputnik V has sown divisions amongst Europe. Last week, Germany announced it would talk to Russia about purchasing Sputnik V, pending EMA approval. “Germany is about to start bilateral negotiations with Russia to obtain its Sputnik V Covid-19 vaccine,” a Reuters report said.

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. Last week, Slovakia’s drug regulator said the composition of a batch of Russia’s Sputnik V vaccine delivered to Bratislava last month could not be verified.

“Batches of (Sputnik V) vaccine used in preclinical 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.

However, the vaccine manufacturer has hit back at SUKL and has insisted that all Sputnik V batches have been through “rigorous quality control”. The Gamaleya Institute, the Russian state agency behind Sputnik, tweeted: “All Sputnik V batches are of the same quality and undergo rigorous quality control at the Gamaleya Institute.”

It claimed SUKL had “launched a disinformation campaign against Sputnik V”.

Brazil to inspect Russian plant: According to a Reuters news report, officials from Brazilian health regulator Anvisa will begin inspections of the Sputnik V factory in Russia. The officials aim to clear up questions about production methods needed to apply for emergency use authorization and import to Brazil, it said. Brazils President Jair Bolsonaro has spoken to Russian President Vladimir Putin about buying and domestically manufacturing the drug.

After AstraZeneca, J&J shot reports rare blood clots; FDA recommends pause in use

The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have recommended pausing the use of the Johnson & Johnson vaccine after a small number of people experienced “a rare and severe type of blood clot” after receiving the shot.

In a statement, the federal health agencies said they were “recommending a pause in the use of this vaccine out of an abundance of caution.”

On Wednesday, the agencies said they wanted more data before deciding whether to resume use of the J&J vaccine or not. They will reconvene in a meeting within 10 days to take a decision.

In the US, around 7.5 million people have received the single-shot vaccine. Of these, six women between the ages of 18 and 48 developed blood clots and one person has died, the FDA has said. Right now, these adverse events appear to be extremely rare.

J&J said it was aware of the blood clots, but “no clear causal relationship has been established between these rare events” and its shot.

Meanwhile, Denmark became the first country in the European Union to drop AstraZenecas vaccine from its Covid-19 inoculation program amid concerns over serious side effects. The Danish Health Authority will continue the rollout of its vaccination program without AstraZeneca,” according to a statement issued on Wednesday.

Sanofi to set up cutting edge mRNA vaccine manufacturing facility in Singapore

Sanofi has been investing in its global vaccine network. Last month, the company said it would invest over US$ 715 million ( €600 million) in a flu shot factory in Toronto, slated to produce its Fluzone high-dose vaccine. When it opens in 2026, the plant will supply shots to Canada, Europe and the US.

In a second vaccine push this year, the French drugmaker is investing over US$ 475 million (400 million) into a new vaccine production site in Singapore, poised to boost supply in Asia and complement Sanofi’s existing manufacturing footprint in Europe and North America.

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

The project is now entering the design phase, with construction expected to kick off in the third quarter of 2021. The site should be fully operational by the first quarter of 2026 and will create up to 200 jobs in Singapore over the next five years, Sanofi said.

Sanofi buys Tidal Therapeutics: Sanofi has agreed to acquire Massachusetts-based biotech Tidal Therapeutics, which is developing messenger RNA-based treatments for cancer. Tidal is a small, privately held biotech and the French drug giant will pay US$ 160 million upfront to acquire Tidal and another US$ 310 million in milestone payments.

Although mRNA is now famous as a platform for infectious disease vaccines, Tidal Therapeutics has been developing it largely for applications in immuno-oncology.

We anticipate that this next generation, off-the-shelf approach has the potential to bring CAR-T cell therapy to a much broader patient population,” Sanofi’s CSO Frank Nestle said in a statement.

Cavazzoni named new director of FDA’s CDER; Woodcock’s leadership yet to be finalized

Patrizia Cavazzoni has been named director of the US Food and Drug Administrations Center for Drug Evaluation and Research (FDAs CDER). Cavazzoni had joined the FDA in 2018 to serve as deputy director of operations for CDER after working at Pfizer for years.

For the past year, Cavazzoni has been the acting director of the CDER. She was appointed to the position when Janet Woodcock left to assume the role of heading the therapeutics arm of Operation Warp Speed (OWS). Woodcock left OWS in January 2021, when Stephen Hahn stepped down as the FDA commissioner during the transition to President Joe Bidens administration.

Since then, Woodcock has been serving as the acting commissioner of the FDA. Three months into the Biden administration, Woodcock remains acting director.

Woodcock said in a letter to staff: “This action means that my official position of record is now the Principal Medical Advisor to the Commissioner, a position I was detailed to last year. Of course, Im also serving as your Acting Commissioner.”

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Image Credit : Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0

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