US to distribute 6.4 million Covid vaccine doses in first tranche

The United States plans to distribute 6.4 million doses of the Pfizer-BioNTech Covid-19 vaccine in the first week after it is cleared for emergency use, which is likely next month, officials said Tuesday.

A committee of the Food and Drug Administration meets on December 10 to decide whether to green light the medicine, with the US confronted by soaring numbers of deaths and new cases.

Latest figures on Tuesday showed that the country had recorded a total of 259,600 Covid deaths and 12.5 million cases -- with over 2,000 deaths and 167,000 new cases in just the last 24 hours.

General Gustave Perna, chief operations officer for the government's Operation Warp Speed, told reporters some 40 million doses of vaccine would be available by the end of December.

That figure includes another vaccine developed by Moderna and the National Institutes for Health, which announced some preliminary efficacy results last week and is also close to applying for emergency approval.

The Pfizer vaccine has ultra-cold long-term storage requirements of -70 degrees Celsius, and the company has developed special containers with dry ice to keep it cool for up to 15 days.

Perna said that 64 jurisdictions across the US -- including the 50 states, territories like the capital Washington and Puerto Rico and Indian reservations -- received their allocation numbers on Friday.

The amount they receive will be proportionate to their population size.

The federal government will issue recommendations for who should be prioritized -- likely the elderly, high-risk, and frontline workers -- but local authorities will make the final decision for themselves.

Vaccinations will begin in retirement homes within 48 hours of the emergency approval, health secretary Alex Azar said. The government has partnered with CVS Health for the retirement home program.

German vials in spotlight

As expectations grow that the first Covid-19 jabs will be administered in a matter of weeks, German glassmaker Schott is quietly doing what it has been for months: churning out vials that will hold the vaccine.

The 130-year-old company, whose founder Otto Schott invented the high-quality borosilicate glass favoured by the pharma industry, has been working round the clock to meet unprecedented demand.

Already it has delivered millions of the little bottles to vaccine makers involved in Covid-19 trials, who have already started filling them so they can be shipped out the minute regulators give the okay.

While non-disclosure agreements prevent Schott from detailing its customer list, head of communications Christina Rettig said they include "the ones you hear about in the media".

In fact, Schott is supplying vials for three-quarters of the more than 100 coronavirus vaccine trials worldwide.

Closest to the finish line are US firm Moderna and a joint effort by US giant Pfizer and Germany's BioNTech -- which coincidentally has its headquarters in the same western German city of Mainz as Schott.

Large-scale data has shown both vaccines to be around 95 percent effective and US and European authorities have signalled that inoculations could start in mid-December.

With the world on the brink of a mass immunisation effort to end the pandemic, Schott and its competitors say they are ready to rise to the challenge.

The company issued a statement in July with Germany's Gerresheimer and Italy's Stevanato Group, fellow leaders in pharmaceutical packaging, to say they were coordinating closely with pharma customers and could ensure sufficient supply.

Schott alone aims to produce enough vials to store two billion doses of a coronavirus vaccine by the end of 2021, Rettig told AFP at the company's offices in Mainz.

- Ramping up -

In a lucky break, the industry was already seeing rising demand from China and other countries for top-level Type 1 borosilicate glass products, meaning Schott and other major players were building up capacity well before the pandemic struck.

Schott launched a $1.0-billion (840-million-euro) investment programme in 2019 to expand its pharmaceutical business. By the time the Covid-19 vial requests started pouring in, new manufacturing equipment was already up and running.  

"That puts us in a very good position to ramp up production quickly," Rettig said.

And because regulators have long been familiar with the tried-and-tested vials, which have to meet strict international norms, they won't hold up the vaccine authorisation process.

To keep production moving, workers are churning out vials 24 hours a day, a typical pace in the sector, and outsiders are banned from the premises to minimise the risk of coronavirus infections.

Schott itself had an early encounter with the virus at its Mitterteich plant in Bavaria, where it manufactures glass tubes that can be turned into vials.

The town became one of Germany's first coronavirus hotspots in March after a beer festival, and Rettig said several Schott workers from the Czech Republic ended up "not seeing friends and family for weeks" as borders slammed shut.

- 'Gold standard' -

Borosilicate glass was invented around 1890 by Otto Schott, a chemist from a family of glassmakers. Together with scientists Ernst Abbe and Carl Zeiss, he set up a lab that would lay the foundation for modern glass technology.

What makes borosilicate glass special is that it can handle temperatures from -80 to 500 degrees Celsius, which is handy considering the Pfizer/BioNTech vaccine needs to be stored at a frigid -70 degrees.

It is also chemically inert, meaning there is no chemical interaction between the container and the liquid inside it, preventing any interference that could potentially harm the vaccine.

Borosilicate glass is considered "the gold standard" for packaging drugs, Rettig said.

The Schott company, wholly owned by the Carl Zeiss Foundation, now has over 16,000 employees in more than 30 countries and reported revenues of 2.2 billion euros ($2.6 billion) in 2018-2019.

Its other products range from specialist cabin lighting in aeroplanes to ceramic cooktops, as well as microscope slides being used in rapid Covid-19 antibody testing, and medical lights that help doctors examine respiratory tracts.

While vial makers aren't quite grabbing the headlines as much as vaccine developers, Rettig said Schott employees "are proud to contribute to the fight against the coronavirus".