Home » Covid-19: Pharmaceutical companies in a race to secure emergency authorizations

Covid-19: Pharmaceutical companies in a race to secure emergency authorizations


According to the worldometer, the Covid-19 pandemic has killed nearly 1,6 million people in the world, and recorded 70 millions positive coronavirus cases until date.Pharmaceutical companies such as Pfizer/BioNTech, Moderna, Sputnik and AstraZeneca, Sinopharm have all started clinical trials of their respective vaccines.

As a member of the Gavi Alliance, Mauritius had already made sure to be able to access a vaccine against Covid-19, regardless of the producer. Dr Laurent Musango, representative of the World Health Organization, said the Mauritian government “has already paid for 240,000 vaccines. Afterwards, the country can see for the remaining 80% of its population ”.

Pfizer/BioNTech and Moderna are both using the same vaccine approach called the mRNA vaccine approach which is a new type of vaccine approach. 

According to Centers for Disease Control and Prevention, mRNA vaccines take advantage of the process used by cells to make proteins to trigger an immune response and build immunity to SARS-CoV-2, the virus that causes COVID-19. 

On the other hand, most vaccines use damaged or inactivated forms or disease-causing pathogen components to enhance the body’s immune response to antibodies.

MRNA vaccines have many advantages relative to other forms of vaccines, including the use of a non-infectious element, faster processing times, and a possible targeting of several diseases. 

MRNA vaccines can be produced in a laboratory using a DNA template and materials that are readily accessible. 

This means that the process can be standardized and scaled up making vaccine development faster than traditional methods.

Pfizer/BioNTech phase 3 trial final analysis revealed that the vaccine showed it was up to 95% effective. The pharmaceutical company also revealed last month that the vaccine even prevented infections in older adults and caused no serious concerns. 

On the 2nd of December, Pfizer obtained the emergency authorization from the UK, 7 months after the clinical trials, making the UK the first country to have authorized a vaccine.

The UK health department made sure that the approval followed months of rigorous clinical trials and a thorough analysis of the data by the Medicines and Healthcare products Regulatory Agency (MHRA), which concluded that the vaccine has met “the strict standards of safety, quality and effectiveness”.

Pfizer and BioNTech CEOs were both elated about the emergency authorization. “This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

We believe that the roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

Following the roll out, Margaret Keanan, 90 years old, has become the first person in the world to have received the jab as part of a vaccination programme to which she added: “My advice to anyone offered the vaccine is to take it – if I can have it at 90 then you can have it too!”

Allergic Reactions and other side effects

The Pfizer/BioNTech vaccine however faces one hurdle as two health care workers experienced an allergic reaction after receiving a shot the day before. To which the UK health authorities said people with a significant history of allergic reactions should not be given the Pfizer/BioNTech coronavirus vaccine. 

According to Pfizer and BioNTech documents released, 10 December 2020, to the FDA as part of the application for an emergency use authorization, nearly 63% of trial volunteers complained of fatigue, 55% experienced a headache, 38% had muscle pain, nearly 32% had chills, and 14% spiked a fever. 

In this same report, several cases of  more severe adverse effects were noted. These concern up to 4.6% of the subjects tested. These included one case of swollen glands and another case of injury to the shoulder after the vaccine was injected. Four cases of “Bell’s palsy” are also counted among the vaccinated patients.

Pfizer is currently in a race to become the first jab to be cleared for use in the US as Moderna seeks for emergency approval as well.

The Food and Drug Administration’s (FDA) vaccine advisory panel met on the 10th of December to debate whether the vaccine is safe and effective enough to be cleared for emergency use before the US decides whether or not they will begin shipping millions of doses of the jab.

The FDA has issued the first emergency use authorization on Friday 11 December for the Pfizer/BioNTech covid-19 vaccine in individuals 16 years of age and older. 

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn

The FDA scheduled a virtual press conference on Saturday 12 December on the first Covid-19 vaccine authorization at 9 am. 

During the virtual press conference, FDA Commissioner Stephen M. Hahn announced the authorized emergency use of the Pfizer/BioNTech covid-19 vaccine and expressed:

“ The FDA is respected worldwide and is considered the gold standard regulator of medical products, we applied our high standards of review in reviewing this product so that Americans can have trust and confidence that the vaccine meets the FDA’s rigorous standards for safety and effectiveness,” he said. 

The virtual conference further took questions about the Pfizer/BioNTech vaccine for discussion. 

The Pfizer vaccine has already been approved in the UK, Canada, Bahrain, Mexico, and Saudi Arabia, and now the USA. 

The other pharmaceutical vaccines such as the Oxford University/AstraZeneca have a 62-90% effectiveness, while Moderna has reached 95% and Sputnik V is with 92% efficacy.

An experimental coronavirus vaccine developed by Chinese state-owned pharmaceutical giant Sinopharm has 86% efficacy, the United Arab Emirates Health Ministry said in a statement Wednesday. Clinical trials included 31,000 volunteers across 125 nationalities in the UAE. 

Sinopharm’s shot makes use of killed or weakened coronaviruses, a technique similar to the one used to generate polio immunizations or the influenza while the vaccine approach used by Pfizer/BioNTech is new and has never been approved before. 

Inactivated virus vaccines take longer to make because batches of the coronavirus must first be grown and then killed using a chemical or heat, and then made into a vaccine that can be injected to elicit an immune response.

The Sinopharm vaccine has been authorized for emergency use in a number of countries and the firm is still running late-stage clinical trials in 10 countries. Morocco is designing an aggressive Covid-19 vaccination campaign to vaccinate 80 per cent of its adults in an operation beginning this month that initially depends on the Sinopharm vaccine.

Information about Sinopharm’s covid-19 vaccine remains unclear as data from their phase 3 trial is yet to be published.

In Russia, with the Sputnik vaccine 92% efficacy, an independent polling institute the Levada Center found that 59 % of the respondents would not get the coronavirus vaccine even if it was free of cost and voluntary. 27% of Russians however believe in the coronavirus vaccine. 

Volunteers on the other hand say that the vaccine seems to help the body form antibodies without serious side effects.

Russia’s health minister, Mikhail Murashko, said on Wednesday that 100,000 people have been vaccinated out of 140 million people.

mRNA VACCINE (2 doses)Pfizer, Moderna
VECTOR VACCINES (1-2 doses)AstraZeneca, Janssen, Sputnik
PROTEIN SUBUNIT VACCINE (1-2 doses)Novavax, Sanofi
Source: BBC News