Thursday, November 4, 2021

Moderna lowers forecast for 2021 Covid-19 vaccine deliveries

Moderna is scaling back expectations for the number of vaccine deliveries it expects to make this year and the revenue it will record from them.

Issues including longer delivery lead times for exports and a temporary impact from expanding the company's capacity to fill vials with vaccine and package them for shipping, which may shift some deliveries to early 2022, the drugmaker said Thursday. 

The company now expects full-year, 2021 product sales of between $15 billion and $18 billion.

That’s down from a prediction for $20 billion in sales that it made in August.

CEO Stephane Bancel told analysts on Thursday that his company’s issues stemmed from scaling up production so quickly.

He also said the problems are short-term and can be fixed.

“Our supply chain became more complex with increased deliveries to countries around the world,” Bancel said.

Moderna’s work on expanding its capacity is complete and it should see a “positive impact” from that soon, Bancel said. 

The company now expects to deliver between 700 million to 800 million doses this year, down from a previous forecast for 800 million to 1 billion.

Coronavirus kills more than 750,000 in US: Johns Hopkins

More than 750,000 people have died because of the coronavirus since the first death in the US, according to Johns Hopkins University.

The Maryland-based school registered 750,435 deaths and 46.2 million cases on Thursday as the US remains the world’s worst-hit country.

The first fatality occurred in the state of California in early February of 2019.

The grim milestone came despite widespread vaccinations.

More than 425 million doses have been administered in the US and more than 192 million people, 58 percent of the population, have been fully been vaccinated, according to the Centers for Disease Control and Prevention (CDC).

The national public health agency gave final approval earlier this week for Pfizer-BioNTech's vaccine for children aged 5 to 11, making up to 28 million in the age group eligible for the shots.

President Joe Biden said in October that infections are declining in 39 of 50 states and hospitalizations are falling in 38. He said his administration is making progress to "accelerate the path out of this pandemic."

UK becomes 1st to approve take-at-home Covid treatment pill

The UK became the first country in the world to approve a coronavirus treatment pill that can be taken at home, when Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the treatment on Thursday.

The pill, taken orally, is called molnupiravir, and was developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme.

British Health Secretary Sajid Javid said: "Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for Covid-19.

"This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment.”

"We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible,” he added.

The MHRA said in a statement that molnupiravir, also known as Lagevrio, "is safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate Covid-19 who are at increased risk of developing severe disease.”

EU regulator reviewing data on AstraZeneca booster shots

The European Union's drug regulator has said that it was in discussions with AstraZeneca over possible authorisation of booster doses of the drugmaker's Covid-19 vaccine, after it already gave the green light to mRNA booster shots.

"AstraZeneca is submitting data to us. Actually today they submitted a new package of data that could support an extension to use the booster," the European Medicines Agency's head of vaccines strategy, Marco Cavaleri, said at a briefing.

"We will be discussing with them whether this data could be sufficient for (authorisation) or whether we need more evidence," Cavaleri added.

Number of cases again reaching record in European region

Every country in Europe and Central Asia faces the threat of a Covid-19 resurgence, the World Health Organization’s Europe region head has said, voicing “grave concern” as cases again reach record levels.

“Last week, with nearly 1.8 million new cases and 24,000 new deaths reported, Europe and Central Asia saw a 6 percent increase and 12 percent increase, respectively, as compared to the previous week,” said Hans Kluge on Thursday.

Over the past four weeks, he observed that Europe has seen a greater than 55 percent increase in new Covid-19 cases.

“The current pace of transmission across the 53 countries of the European region is of grave concern,” Kluge said, noting that the more transmissible Delta variant is continuing to dominate transmission.

He said that where vaccine uptake is low, hospital admission rates are high in many countries in the Baltics, Central and Eastern Europe, and the Balkans.

The European region, extending from Greenland in the northwest to the Russian Far East, is seeing rising trends across all age groups, he said.

The rapid climb in the older population groups is of greatest concern, he said, translating into more people with severe disease and dying.

New US testing/vaccine rule excludes outdoor workers

A new US workplace rule that requires tens of millions of Americans to get vaccinated for Covid-19 or submit to weekly testing will exclude employees who work exclusively outdoors, according to regulatory filing by the Occupational Safety and Health Administration.

An estimated 2.4 million healthcare workers will need to be vaccinated or replaced under a related rule issued by Centers for Medicare & Medicaid Services. 

Britain records 37,269 new cases, 214 deaths

Britain has reported 37,269 new Covid-19 cases, down from the previous day, and a further 214 deaths within 28 days of a positive coronavirus test, the third day in a row with more than 200 deaths.

Cases over the last seven days are down 6.9 percent on the previous seven days.

WHO says reserve Covid-19 boosters for immunocompromised

The World Health Organization has called for vaccine makers to prioritise deliveries of  jabs to the COVAX dose-sharing facility for poorer countries and said that no more doses should go to countries with more than 40 percent coverage.

Tedros Adhanom Ghebreyesus, WHO Director-General, said that boosters should not be administered except to people who are immunocompromised.

"We continue to call on manufacturers of vaccines that already have WHO Emergency Use Listing to prioritize COVAX, not shareholder profit," he said.

The WHO listing of Indian drugmaker Bharat Biotech's Covaxin on Wednesday contributes to vaccine equity, he added.

Russia's daily Covid-19 death toll hits record high

Russia's daily Covid-19 death toll has reached a record high of 1,195 amid a surge in cases that has forced officials to impose a nationwide workplace shutdown.

The government coronavirus task force also reported 40,217 new infections in the past 24 hours, including 6,305 in Moscow. 

Russia’s weekslong surge in infections and deaths comes amid low vaccination rates, lax public attitudes toward taking precautions and the government’s reluctance to toughen restrictions.

Less than 35 percent of Russia’s nearly 146 million people have been fully vaccinated against the coronavirus, even though Russia approved a domestically developed vaccine against the coronavirus months before most countries.

German cases hit daily record 

Germany has reported 33,949 new Covid-19 infections, the highest daily increase since the start of the pandemic last year.

Countries across Europe have been reporting rises in coronavirus infections, prompting debate over whether to reintroduce restrictions and how to persuade more people to get vaccinated.

The daily number of cases was likely inflated by a public holiday in parts of Germany on Monday that led to a delay in data-gathering. The previous record was on December 18, with 33,777 cases. 

Hungary reports jump in daily infections

Hungary has reported a jump in daily infections to 6,268, with the daily tally more than doubling from the middle of last week, the government said.

Hungary, a country of 10 million, has reported 31,101 deaths since the start of the pandemic. Only 5.74 million of its people are fully vaccinated against the virus, below the European Union average. 

Poland's daily cases top 15,000 for first time since April

Poland has reported 15,515 daily Covid-19 cases, health ministry data showed, the highest total since April.

There were 250 Covid-related deaths reported. Poland, a country of around 38 million people, has reported 3,060,613 cases of the coronavirus and 77,395 deaths since the beginning of the pandemic.

France reinstates mask requirement in 39 areas

Face masks will become obligatory again in schools in 39 regional departments of France where Covid-19 cases have crossed the alert threshold, a government spokesman said. 

As schools in the country reopen on November 8 following brief holidays, the mask rule will be reimposed for primary schools amid concerns over daily new cases, Gabriel Attal said at the weekly press conference.

The 39 departments are in addition to the 22 departments where masks were declared compulsory last month, taking the total to 61, or nearly half of the French territory.

England sees record virus prevalence in October – Imperial study

Virus prevalence in England rose to its highest level on record in October, Imperial College London said, led by a high numbers of cases in children and a surge in the south-west of the country.

Nearly 6 percent of school-aged children had the virus, the researchers found, although there was a drop in prevalence towards the end of the study's period coinciding with the closure of schools for half-term holiday.

Turkey to start booster shots for BioNTech vaccine recipients – minister

Turkey will begin administering boosters to people who have received two shots of the BioNTech coronavirus vaccine, Health Minister Fahrettin Koca said.

Turkey has already administered a third dose to more than 11.2 million people who received two doses of the vaccine developed by China's Sinovac, whose efficacy rate officials believe falls faster.

In a statement after meeting with his science council, Koca said the booster shots for BioNTech recipients would begin on Thursday with the elderly, those with chronic illnesses, health workers and those in other high-risk jobs.

Brazil registers 164 deaths

Brazil registered 164 deaths and 14,661 additional cases, according to data released by the nation's Health Ministry.

The South American country has now registered a total of 608,235 deaths and 21,835,785 total confirmed cases.

Puerto Rico to make vaccine mandatory for school

Puerto Rico’s governor said that officials will start vaccinating children ages 5 to 11 this week against the virus, and that getting the vaccine will be required to attend school in person with few exceptions.

Health Secretary Carlos Mellado said he anticipates that some 227,000 children will be vaccinated, with a goal to inoculate 95 percent of that population.