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Schedule, production and costs: the keys to the countdown to the coronavirus vaccine

2020-12-04T06:57:25.270Z


One year after the discovery of the coronavirus, Europe takes the first step in a massive immunization process that can last for much of 2021


The European Union has started the countdown receiving the first doses of vaccines against Covid-19, which has already caused the death of more than 400,000 people on the continent.

Thus, almost a year after the start of the pandemic from Wuhan (China) and after an unprecedented investigation to achieve immunization against the SARS-CoV-2 virus, the European Medicines Agency (EMA) has started its engines to give its approval in six weeks to the first candidates: the Pfizer / BioNtech and Moderna vaccines. 

Despite the fact that the United Kingdom has given express approval to Pfizer and BioNtech, - which places the former EU partner only one week from starting vaccination - the community block has some boxes left to verify in the request of the laboratories .

The pharmaceutical companies, which have also requested authorization in the US, await the positive verdict of the EMA to activate the manufacturing machinery and its distribution, with significant logistical challenges, to deliver their vaccines to the entire EU.

A full stop to close a historic 2020, marked health and economically by the pandemic, although total immunization may take most of 2021.

When will the use of vaccines be approved in the European Union?

The EMA announced on Tuesday that the Committee for Human Medicines (CHMP) will conclude its evaluation of the safety and efficacy of Pfizer's Covid-19 vaccine on December 29 and Moderna's vaccine on January 12.

The authorization requested by the pharmaceutical companies is a "conditional approval", that is, its immediate availability will be allowed to be distributed in the EU countries, but the companies will have to continue carrying out the studies during the next year to transform it into a permanent approval.

Furthermore, as it is a conditional marketing authorization, the risk of liability for the vaccine and side effects lies, not with the EU states, but with the laboratories that have developed the injectables.

Both pharmaceutical companies requested approval from the EMA after confirming in November the effectiveness of their vaccines, 95% from Pfizer and 94.1% from Moderna.

The EU also has a contract with other antidote developers, such as AstraZeneca, Sanofi or Janssen, which are somewhat more delayed.

The European Commission, in charge of negotiating on behalf of the Twenty-seven agreements with the pharmaceutical companies that are developing the vaccines, assured this Tuesday that the approval of the Von der Leyen Executive "will be a matter of days" once the committee of experts.

When will vaccines be available in Europe?

Moderna, which manages a distribution channel for the United States and another for Europe, has indicated that the supply of its vaccine to the European bloc will not be available until early next year, while Pfizer has advanced the production of its candidate since October and is awaiting EMA approval for distribution in the EU.

"We have been accumulating stocks, and all of them can be distributed in hours," Sierk Poetting, head of BioNtech operations, told Reuters on Tuesday.

Where will the vaccines be made?

In July, Moderna closed an agreement with the Spanish company Rovi to manufacture its vaccine against Covid-19 from the Madrid laboratory that, as explained to the CNMV, will begin production in January.

The Spanish company will not manufacture the active principle of the vaccine, but will be in charge of producing the vials, thawing, packaging and labeling the active principle.

Rovi will take over the global manufacturing of Moderna's vaccine (except for the US market).

For its part, the American pharmaceutical company Pfizer has carried out the mass production of its vaccine prototype from its factories in the United States and Belgium.

The biggest challenge for the American company and its German partner BioNtech lies in the fact that the vaccine must be distributed at 75 degrees below zero.

To achieve this, the multinational will use 40 of its own distribution support centers and more than 200 suppliers around the world, in a chain that involves tons of dry ice.

In health centers, the vaccine will be stored in ultra-low temperature freezers, which have a shelf life of up to six months, and can be kept refrigerated between two and eight degrees for just five days.

How will vaccines be distributed in the EU?

The EC agreements establish that the 1,305 million vials, agreed so far in six contracts for almost 20,000 million euros, will be distributed proportionally to the population of the EU partners, which represents almost 10% of stocks for Spain.

Thus, of the main candidates, the community bloc has already closed the purchase of 200 million Pfizer vaccines, with the option to purchase another 100, and of which 20 million would correspond to Spain.

The Von der Leyen Executive has agreed a price of 15.5 euros per dose, which represents an expense of about 3,100 million euros that would allow the vaccination of about 100 million community citizens.

In addition, after the confirmation of 94.1% of the effectiveness of Moderna, Europe last week signed the purchase of up to 160 million doses of its vaccine, of which Spain would receive about 14 million.

This Wednesday, the Executive of Pedro Sánchez has approved the purchase of the first eight million, for an invoice of almost 170 million euros.

The EC has also agreed to purchase 200 vaccines from Janssen, for 1.7 billion euros, 300 million doses of AstraZeneca, for 870 million, and 225 million from CureVac, for about 2.25 billion euros.

When will the vaccination start in Spain?

According to the Minister of Health, Salvador Illa, the campaign could start in January and in May there could be a large part of the Spanish population vaccinated against Covid-19.

For this, the minister presented in November a Vaccination Plan that will be developed in three phases, distributed throughout 2021 and giving priority to risk groups.

Given that the vaccine will not be mandatory, Illa has relied on the "strong tradition of vaccination" that Spain has to vaccinate "very high percentages of the population."

Who can get vaccinated first?

In the context of limited supply, priority will be given to healthcare workers, the elderly and residents of long-term care facilities in accessing vaccines, as recommended by the European Technical Advisory Group of Experts on Immunization (ETAGE) of the World Health Organization (WHO).

In the case of Spain, the Vaccination Plan of the Ministry of Health has divided access into three phases.

In the first, between January and March, the vaccine will be applied to the elderly in residences and the staff who care for them, other health personnel and people with disabilities, non-institutionalized dependents.

This first group totals almost 2.5 million people.

Then, from March to June, the vaccination groups will be expanded as the acquisition of more doses increases and always determining the groups according to three criteria: greater risk of serious disease or mortality;

greater transmissibility and greater socioeconomic impact.

Finally, in a third phase from June to the end of the year, "there will be doses of vaccines to vaccinate 100% of the population" in 2021, according to Illa.

Where will the vaccinations take place?

Some 13,000 outpatient clinics and health centers distributed throughout Spain will be the spaces to carry out the Vaccination Plan proposed by the Government.

What is the price of the vaccine?

Moderna manages the highest price so far, with an estimated 25 dollars per dose (about 20 euros), while the EC has agreed to pay Pfizer about 15.5 euros for each dose, which rises to 40 and 31 euros, respectively, the price of the vaccine, since two doses are needed to ensure immunity. 

Only with the Pfizer contract, the cost closed by Brussels would mean a bill of 3,100 million for 200 million doses, which would increase to 4,650 million if another 100 million optional vials contemplated in the commercial agreement are purchased.

In this context, the Ministry of Health of Spain has recalled in the presentation of the Vaccination Plan that it has among its objectives to guarantee that vaccination is free and thus reduce mortality.

Will vaccines get to other countries first?

Until now, the US calendar was the most advanced to give the green light to the candidates of US laboratories, but the British government became the first country in the world to approve the Pfizer and BioNtech vaccine on Wednesday.

The first 800,000 doses will be available in the country from next week, according to British Health Minister Matt Hancock, and priority will be given to older people, those in nursing homes and healthcare personnel.

Regarding the US advance, Pfizer is expected to receive the go-ahead from the US Food and Drug Administration (FDA) on December 10 for its vaccine.

If the US regulator approves its efficacy and safety, Pfizer could distribute 50 million doses of vaccine to the United States before the first half of December, which would allow the immediate protection of 25 million people in the country.

For its part, Moderna, which will measure 94.1% of its candidate on December 17 before the FDA, could supply some 20 million doses to the United States in a period of 24-72 hours after approval.

If they pass Pfizer and Moderna, what happens to the other vaccines?

Pfizer and Moderna, with more than 90% effectiveness, are at the forefront of an unprecedented investigation that already has 47 vaccines in clinical trials.

Together with the American laboratories, the British AstraZeneca candidate also went through the last stage of tests with thousands of volunteers in November to receive health clearance.

However, a week after the report of Moderna's vaccine effectiveness, AstraZeneca mistakenly announced its candidate's 70% effectiveness.

The ruling has forced the company to take a step back in the race to find the antidote to the coronavirus and has announced that they will conduct new clinical trials in the United States to evaluate the dose that worked best in their previous studies and finally request the EMA approval.

The British vaccine has one of the largest contracts closed with the European Commission, with which it has agreed to supply 300 doses for the EU, with the option to buy 100 more, at an average price of 2.5 euros.

Another of the large contractors in Europe is the German biotechnology company CureVac, which is preparing a network of production plants with partners in the EU, including Spain, which will allow it to increase the manufacture of its experimental Covid-19 vaccine to 300 million doses in 2021 and up to 600 million in 2022. However, this company is still in phase two of the investigation and expects to receive authorization in the third quarter of 2021.

CSIC researcher Luis Enjuanes has indicated the existence of several candidates as "positive" news.

"It is very positive that there is a collection of vaccines. This would even give the possibility of carrying out the first immunization with one type of vaccine and the second with another", explained Enjuanes, rescuing that this combination would allow a better response in the vaccination.

Source: elparis

All news articles on 2020-12-04

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