Pfizer’s experimental oral COVID-19 antiviral therapeutic could be ready by the end of the year, the company’s chief executive officer (CEO) Albert Bourla (pictured) told CNBC.

If all goes well in clinical studies for the drug, it could be available for the treatment of patients in the US by the end of 2021, according to Bourla.

The oral antiviral clinical candidate – known as PF-07321332 – is a SARS-CoV-2-3CL protease inhibitor, designed to bind to a viral enzyme and thereby prevent the virus from replicating in the cell.

The drug has already demonstrated potent in vivo antiviral activity against SARS-CoV-2, according to Pfizer, as well as activity against other coronaviruses.

Previously, protease inhibitors have been shown to be effective for the treatment of other viral pathogens, including HIV and hepatitis C virus when used alone or in combination with other antivirals.

The phase 1 trial has completed the dosing of single ascending doses of the drug in healthy adults and has since progressed to testing multiple ascending doses.
Pfizer is also investigating an intravenously administered investigational protease inhibitor – PF-07304814 – which is currently in a phase 1b multi-dose trial in hospitalised participants with COVID-19.

“We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalised or in critical care,” said Mikael Dolsten, chief scientific officer and president, worldwide research, development and medical of Pfizer.

The world can bring the COVID-19 pandemic under control in a ‘matter of months’, the World Health Organization’s (WHO) director general Tedros Adhanom Ghebreyesus (pictured) said during a news briefing.

In the news briefing, Ghebreyesus added that the WHO has expressed its interest in establishing a ‘COVID-19 technology transfer hub’ for mRNA vaccines, in a bid to bolster production of this type of vaccine in low- and middle-income countries.

“We are calling for the original manufacturers of mRNA vaccines to contribute their technology and know-how to a central hub, and for manufacturers in low- and middle-income countries to express interest in receiving that technology,” he added.

The call for technology transfer follows the news that over three million deaths from COVID-19 have been reported to WHO across the globe.

Ghebreyesus said that infections and hospitalisations are also growing among people aged 25 to 59 ‘at an alarming rate’ due to highly transmissible variants and increased social mixing among younger adults.

This includes variants discovered in the UK, Brazil, South Africa and most recently India.
In particular, the Indian variant – also known as B.1.617 – has some ‘potentially’ important mutations that could help it escape some immunity.

Roll out of Johnsons & Johnson’s (J&J) COVID-19 vaccine has resumed in the US after the US Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) recommended lifting the temporary pause on the jab.

The CDC and FDA recommended the pause following six reported cases in the US of a rare and severe type of blood clot – known as cerebral venous sinus thrombosis (CVST) – observed in individuals after receiving the single-dose J&J vaccine.

In these cases, the rare blood clots were seen in combination with low levels of blood platelets, known as thrombocytopenia.

According to the CDC and FDA, nearly all reports of these events were observed in adult women under the age of 50 years old.

Following its review, the regulators said that at this time, the vaccine’s benefits outweigh its risks, although they added that women under the aged of 50 should be aware of the rare but increased risk of very rare blood clots with low platelets.

“We have concluded that the known and potential benefits of the [J&J] COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older,” said acting FDA commissioner Janet Woodcock.

The European Commission (EC) is moving forward with legal action against AstraZeneca (AZ) over delays of the company’s COVID-19 vaccine to the EU.

The legal proceedings against AZ were confirmed by the EC on Monday 26 April. Spokesperson Stefan De Keersmaeker commented: “On Friday the Commission started legal action against the company AstraZeneca on the [basis] of breaches of the advanced purchase agreement.”

He added: “The reason being the terms of the contract, or some terms of the contract, have not been respected, and the company has not been in a position to come up with a reliable strategy to ensure the timely delivery of doses.”

Earlier this year, AZ said that it would reduce the number of doses of its vaccine delivered to the EU by about 60% in the first quarter of 2021, with the aim of delivering 31 million doses, rather than the originally agreed 80 million doses.

The EC has said that the company will provide 70 million doses in the second quarter of 2021 – significantly less than the initial 180 million expected.

In a statement issued yesterday, AZ said that it ‘regrets’ the EC’s decision to launch legal proceedings over supply issues for its vaccine.

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the overall benefit-risk profile of Johnson & Johnson’s (J&J) COVID-19 vaccine is positive.

The PRAC concluded, however, that a warning regarding unusual blood clots with low blood platelets should be added to the product information for the vaccine, after finding a possible link between the rare adverse events and the jab.

These blood clots mostly occurred in ‘unusual sites’, including in veins in the brain (cerebral venous sinus thrombosis) and in the abdomen (splanchnic vein thrombosis) and in arteries, along with low blood platelets and sometimes bleeding.

PRAC noted that the cases reviewed in relation to the J&J vaccine were ‘very similar’ to cases that occurred with AstraZeneca/Oxford University’s COVID-19 vaccine.

Following its review, PRAC has also concluded that these events should be listed as very rare side effects of the J&J COVID-19 vaccine.

A ‘plausible’ explanation for the combination of blood clots and low blood platelets observed following vaccination could be an immune response, according to the EMA.

This leads to a condition that is similar to heparin induced thrombocytopenia (HIT). This condition can be seen in patients who had been treated with the anticoagulant heparin.

Eli Lilly has cut is 2021 outlook after adjusting its forecast to reflect ‘lower expected revenue’ from its COVID-19 antibody sales, after the emergency use authorisation (EUA) for its bamlanivimab monotherapy was revoked in the US.

In the first quarter, Lilly reported a net income of $1.355bn, down from the $1.457bn reported in the same period last year.

The company did, however, see an overall revenue growth of 16% compared to Q1 2020, excluding revenue from its COVID-19 antibodies as well as approximately $250m of Q1 revenue from increased customer buying patterns and patient prescription trends.

In addition, operating costs also increased to $3.261bn, primarily driven by approximately $220m in research and development costs for its COVID-19 antibody assets.

During an earnings call, Lilly’s chief financial officer Anat Ashkenazi said the company is “narrowing” its range for COVID-19 antibody revenue, from the previously forecasted $1bn to $2bn to the newly adjusted $1bn to $1.5bn. In Q1, the total revenue for Lilly’s COVID-19 antibodies was $650.6m in the US and $159.5m elsewhere.

“Based on the roll out of the vaccine across major markets, current antibody utilisation rate, existing US government bamlanivimab supply and the transition to only supply bamlanivimab and etesevimab administered together in the US, we believe this update range contemplates a variety of potential scenarios,” she added.

As a result, Lilly has also reduced its full year forecast by approximately $400m, and is now projecting that its 2021 revenue will be between $26.6bn. and $27.6bn.