Europe eases travel restrictions; Pfizer, Astra’s vaccines show efficacy against B.1.617.2 (Indian) strain

Europe eases travel restrictions; Pfizer, Astra’s vaccines show efficacy against B.1.617.2 (Indian) strain

By PharmaCompass

2021-05-27Impressions: 1566

Europe eases travel restrictions; Pfizer, Astra’s vaccines show efficacy against B.1.617.2 (Indian) strain

Last week, the world of pharmaceuticals continued to be dominated by pandemic-related news. In the US, the FDA granted an emergency use authorization (EUA) to GSK and Vir Biotechnology’s antibody treatment. However, the agency said for the remainder of the pandemic, it may decline to review and process further EUA requests for Covid vaccines, unless a developer has already engaged with the FDA.

In a study undertaken in the UK, both the Pfizer and AstraZeneca jabs have shown effectiveness against the B.1.617.2 variant of SARS-CoV-2.

As Covid cases reduce, the European Union has agreed to ease restrictions on fully-vaccinated tourists from the US and other countries. These tourists will no longer have to quarantine or be tested.

Moderna and Novavax have signed a deal with the South Korean government to manufacture their Covid-19 vaccines, as the country has been under pressure to secure more and faster deliveries of the US-made vaccines.

In non-Covid news, the UK government has asked officials to keep an eye on Elliott Management’s plans for GSK, since the activist investor bought a major stake in the British drugmaker. And private equity firm Carlyle Group has bought out UK pharma company Vectura for US$ 1.4 billion.


As Covid cases reduce, Europe eases travel restrictions for fully vaccinated tourists

With Covid cases going down in several countries, there is news that the European Union has agreed to ease restrictions on fully-vaccinated tourists from the US and other countries. These tourists will no longer have to quarantine or be tested.

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Ambassadors from the 27 EU countries approved a European Commission proposal from May 3 to soften the criteria to determine safe” countries and allow fully vaccinated tourists from elsewhere to visit the country, a CNBC news report said.

Under current restrictions, people from only seven countries, including Australia, Israel and Singapore, can enter the EU on holiday, regardless of whether they have been vaccinated or not.

The EU is expected to set a new list soon. Based on data from the European Centre for Disease Control and Prevention, Britain and a number of other countries will meet the new criteria.

For inoculated people to gain access, they would need to have received an EU-approved vaccine. Travelers who have received a vaccine from the World Health Organization’s emergency use listing will also be considered.

Italy, Iceland, Greece and Spain now allow or are opening their borders to people whove been vaccinated or who recently tested negative for Covid-19. Among non-EU countries, Israel will end local Covid-19 restrictions following a successful vaccine rollout. With the majority of its population having received the Pfizer-BioNTech vaccine, Israel has been gradually reopening its economy after three lockdowns.

Although vaccinated Americans will be welcome in Europe, the US has not opened its doors for European travelers. Last week the White House said it has no plans to require foreign visitors to the US to be vaccinated for Covid-19.

White House spokeswoman Jen Psaki also said there was no update on when the US might allow in more foreign visitors. Even the WHO has said it is against requiring proof of a vaccine to enter another country given the limited (although growing) evidence about the performance of vaccines in reducing transmission and the persistent inequity in the global vaccine distribution.”


FDA grants EUA to GSK-Vir Biotech’s antibody treatment; to close door on fresh EUA requests for Covid jabs

The US Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) to antibody treatment — Sotrovimab — developed by Vir Biotechnology and GlaxoSmithKline (GSK) for treating mild-to-moderate Covid-19 in people aged 12 years and older.

Sotrovimab is a monoclonal antibody, a drug that mimics natural antibodies that the body generates to fight off infection. The antibody treatment will be available for Covid-19 patients in the coming weeks, the companies said. GSK and Vir Biotech plan to submit a marketing application to the FDA in the second half of 2021.

The antibody drug, Sotrovimab, is not authorized for patients who are hospitalized due to Covid-19 or require oxygen therapy, the FDA said. Similar Covid-19 therapies from Regeneron Pharmaceuticals and Eli Lilly have been granted EUA in the US.

Fresh EUA requests for Covid-19 jabs: In a guidance for the industry, the FDA said this week that for the remainder of the pandemic, it may decline to review and process further emergency use authorization (EUA) requests for Covid-19 vaccines, unless a developer has already engaged with the agency.

The move will push late entrants into the race for the Covid-19 vaccine to go the long route and submit a full BLA with more manufacturing and safety data rather than use the shortened EUA process.

Moderna’s jab approved for adolescents: After the FDA extended the EUA granted to Pfizer’s vaccine earlier this month, there is news that Modernas Covid-19 vaccine has shown to be effective in adolescents aged 12 to 17 years. The Moderna jab showed no new or major safety problems in a clinical trial. As of date, the vaccine is authorized for adults 18 and older.

Moderna said it will submit the findings of its adolescent study to the FDA and other regulators for an EUA in early June. This sets the stage for a second vaccine for school-going children to be authorized in July.

We are encouraged that mRNA-1273 was highly effective at preventing Covid-19 in adolescents," Stéphane Bancel, Moderna’s chief executive, said in a statement.


Both Pfizer and Astra’s jabs show effectiveness against B.1.617.2 strain, says UK study

A study undertaken by Public Health England looked at vaccine effectiveness against the B.1.617.2 variant of the SARS-CoV-2, also referred to as the Indian variant that is behind the massive surge of Covid-19 cases in India. The study is believed to be the first such study on vaccine effectiveness against the variant.

According to the British researchers, both the Pfizer-BioNTech and AstraZeneca Covid-19 vaccines have shown effectiveness against symptomatic disease from B.1.617.2.

Overall, 12,675 cases were sequenced, 11,621 of which were B.1.1.7 (UK/Kent variant) and 1,054 were B.1.617.2. Two doses of Pfizer’s vaccine displayed 87.9 percent efficacy while two doses of AstraZeneca’s showed 59.8 percent efficacy against the B.1.617.2 variant. Vaccine effectiveness after one dose against B.1.617.2 was low for both vaccines — at 33 percent.

While the B.1.1.7 (UK/Kent variant) is the dominant strain in the UK, a study published in the British Medical Journal last week suggested that cases of the B.1.617.2 variant had risen by more than 160 percent. It could be as much as 50 percent more transmissible than the UK variant.

While many are considering this as wonderful news, experts on Twitter beg to differ due to the surge of the B.1.617.2 variant in kids in several cities in the UK, terming the variant as problematic. Moreover, the efficacy of both the vaccines is lower than before for both one dose and two doses, says Eric Feign-Ding, an epidemiologist and health economist.

Meanwhile, Pfizer is reportedly in talks with the Indian government for getting a fast track approval for rolling out 50 million doses of its mRNA vaccine in the country between July and October this year, owing to its effectiveness against the India-dominant variant of the virus. Pfizer is also underscoring the fact that the vaccine can be stored for a month in cold storage facilities with a temperature range of 2 to 8 degrees Celsius.


Moderna, Novavax sign vaccine partnership deal with South Korean government

Late last week, American drugmakers Moderna and Novavax entered into a deal with the South Korean government to manufacture their Covid-19 vaccines in South Korea, as the country has been under pressure to secure more and faster deliveries of the US-made vaccines.

The US President Joe Biden and the South Korean President Moon Jae-in have also agreed on a comprehensive partnership on Covid-19 vaccines. Under this partnership, the US will provide vaccinations for 550,000 South Korean soldiers.

Moderna, whose shot was granted approval in South Korea last week, said its vaccine will be manufactured by Samsung Biologics. Moderna intends to supply these vaccines to markets outside the US, beginning September this year.

South Korea has emerged as a global vaccine production base with its fourth Covid-19 vaccine contract manufacturing deal, Vice Health Minister Kang Do-tae said. South Korea has vaccinated fewer than 10 percent of its 52 million people but aims to inoculate at least 70 percent by September. It has ordered up to 192 million doses of the vaccines made by AstraZeneca, Pfizer, Novavax, Moderna and Johnson & Johnson.

South Korea has also secured deals to locally produce coronavirus vaccines developed by AstraZeneca and Novavax, and Russia’s Sputnik V. The country has secured access to 40 million doses of Moderna’s Covid-19 vaccine, the authorities said.

In February, Novavax had entered into a license agreement with South Korean manufacturer SK Bioscience Co Led to produce 40 million doses of its Covid-19 vaccine for the country.


UK government asks officials to keep a close eye on Elliott Management’s plans for GSK

Last month, activist investor Elliott Management bought a major stake in British drugmaker GlaxoSmithKline. Elliott Management is known to be an aggressive activist’ investor. Last year, it had publicly called on Alexion Pharmaceuticals to sell itself, arguing that the managements steps were leading it in the wrong direction. Alexion got acquired by AstraZeneca in December 2020.

With this reputation of prompting shake-ups at drug companies, there are fears that Elliott Management may push to split GSK or have it acquired by an American rival company.

Therefore, the British government is watching over GSK, and has asked officials to keep a close eye on Elliott Managements plans for GSK. Concerns are mounting that Elliot could agitate for a sale of the entire group or push for a further division of GSK's pharmaceuticals or vaccines unit.

Kwasi Kwarteng, Britains secretary of state for business, energy and industrial strategy, has reportedly asked officials to lend support to CEO Emma Walmsley, who is under pressure to improve GSK’s performance. The British drugmaker has suffered a string of setbacks throughout 2020 and early 2021.

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Elliot’s investment in GSK has coincided with the ongoing restructuring being undertaken by Walmsley. As per the plan, GSK will split into two companies—one focused on biopharma and the other on consumer health. Following the planned completion of the separation, due in mid-2022, GSK will remain solely focused on pharmaceuticals and vaccine products.

Inquiry into Alexion sale: The UKs Competition and Markets Authority (CMA) has opened an inquiry into AstraZenecas proposed US$ 39 billion acquisition of Alexion.

By July 21, the CMA says it will decide whether the deal will result in a substantial lessening of competition within any markets in the UK. The CMA is open to comments on the deal until June 3. But with the US Federal Trade Commission signing off on the acquisition in April, and nine other countries, including Brazil and Canada, following suit, all signs point to a positive result from the UK. More than 99 percent of shareholders at both AstraZeneca and Alexion voted for the deal in separate meetings earlier this month.


Private equity firm Carlyle Group buys out Vectura for US$ 1.4 billion

Vectura has announced that private equity firm Carlyle Group has agreed to buy it out for US$ 1.4 billion.

After working on developing asthma and COPD drugs that failed late-stage trials, Vectura changed its course three years ago. In 2019, it brought in Will Downie, a senior executive of Catalent, as its CEO and executive director and began focusing on helping other companies manufacture their drugs, rather than focusing on drug development.

Vectura now specializes in inhaled medicines. It helps drugmakers formulate their molecules for inhalers or nebulizers, while offering services to help companies scale up their manufacturing processes and analyze their finished products.

It seems like the gamble has paid off, as the Carlyle Group is paying a 32 percent premium on the companys market value.

For Carlyle, Vectura adds to a growing stable of biotech and drug development services companies it has acquired over the last decade or so. It acquired PPD, a contract research organization, in 2011. And in 2017, it bought another CRO — AMRI. In 2020, it bought TriNetX. And last month, Carlyle bought Unchained Labs and its line of gene therapy and vaccine services for US$ 435 million.

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