Pfizer and BioNTech’s mRNA vaccine will most likely hit the markets by the end of 2020:
Pfizer and BioNTech had collaborated to produce an experimental Covid-19 vaccine called BNT162b1. Preliminary human testing of this vaccine had shown promising results against the SARS-CoV-2[1].
The phase 1/2 trials of this vaccine were conducted to establish its safety. Around 45 people aged 18 to 55 were enrolled for this trial. Each participant was given a second dose 21 days after the first dose of the vaccine or the placebo. The study also showed that most of the participants had developed a fever after administration of the second dose. This symptom, however, was revealed to be common post-vaccination.
The results of this trial helped to justify the non-toxic nature of the vaccine and its efficiency in triggering the immune response. (Pharma news – 12 July)
BNT163b1 is heavily dependent on the mRNA for the generation of antibodies against the SARS-CoV-2. It produces antibody responses at low doses. The number of antibodies produced was higher than that seen in the convalescent serum-blood plasma of the recovered patients.
The CEO of BioNTech recently claimed that this vaccine will be tested even more rigorously in the next trial. The upcoming trial will be a much larger one and involve around 30,000 healthy participants. It is expected to begin by the end of July 2020 following regulatory approval.
The companies are awaiting the marketing approval to produce around 100 million doses of this vaccine by the end of 2020. Another 1.2 billion doses is also expected to be produced by the end of 2021 at various sites in the United States and Germany.
Abbreviation: 1. Severe Acute Respiratory Syndrome – Coronavirus -2
Biocon’s Itolizumab injection receives DCGI’s approval for treating Covid-19: Pharma news – 12 July
The rapid spread of Covid-19 has forced the DCGI[1] to ]approve repurposed drugs under the emergency use authorization. This includes the antiviral remdesivir and the immunosuppressant tocilizumab. Besides, the antimalarial drug hydroxychloroquine, and the steroid dexamethasone were also approved for use in Covid-19 patients.
Recently the DCGI approved another drug for treating the moderate to severe Covid-19 patients. This drug is called Itolizumab and is manufactured by Biocon Ltd. The approval was obtained only after submission of the phase-II clinical trial results to prove its efficacy in Covid-19 patients.
The trials were conducted at multiple hospitals in New Delhi and Mumbai. These randomized controlled trials were done to check the safety and efficacy of Itolizumab.
Lok Nayak hospital was one of the sites of the Itolizumab study. Around eight patients from this hospital were recruited for the study. The initial oxygen saturation level of these patients was less than 80%. These patients had slim chances of survival prior to the trial. However, following the administration of a single dose of Itolizumab most of these patients survived.
The Union Health ministry stated that the results of this trial were discussed by the Subject Expert committee. The results include extensive details about the oxygen saturation level, lung function and patient mortality rate following administration of the drug. The results also showed that Itolizumab reduced the levels of inflammatory markers like IL-6[2], TNFα[3] thereby preventing hyper-inflammation in Covid-19.
Following the analysis of these results, the DCGI approved its use for treating the Cytokine Release Storm in moderate to severe Covid-19 patients.
The company stated that the intravenous injection of Itolizumab will be manufactured at the Biocon Park, Bengaluru.
The emergency use authorization involves specific protocols, and these must be fulfilled before the administration of the drug. This includes informing the patients about the possible risks and benefits of this drug before treatment. The treatment is started only after receiving the patient’s written consent and setting up a risk management plan. The risk management plan helps to manage the adverse effects. These drugs are also allowed to be used in hospitals and medical institutions alone. They are not permitted to be sold in retail pharmacies.
Itolizumab is an immunomodulating anti-CD6[4] monoclonal antibody. It is used for the treatment of severe to chronic plaque psoriasis. Itolizumab is sold under the brand name Alzumab and has been in use since 2013. Monoclonal antibodies are proteins that are made in the laboratories. These antibodies produce an immune response that is similar to the ones produced by natural antibodies.
Abbreviations: 1. Drugs Controller General of India
2. Interleukin – 6
3. Tumor necrosis factor – alpha
4.Cluster of Differentiation 6
References:
[1] – pfizer-biontech-s-covid-vaccine-expected-to-be-ready-for-approval-by-year-end-Live Mint – 10 July 2020
[2] – dcgi-approves-limited-use-of-psoriasis-injection-for-covid– Hindustan Times – 12 July 2020